Apple to require employee proof of COVID-19 booster: The Verge

Apple Inc will require retail and corporate employees to provide proof of a COVID-19 booster shot, The Verge reported, citing an internal email.

Starting Jan. 24, unvaccinated employees or those who haven't submitted proof of vaccination will need negative COVID-19 tests to enter Apple workplaces, the report said. The Verge said it was not immediately clear if the testing requirement applies to both corporate and retail employees.

"Due to waning efficacy of the primary series of COVID-19 vaccines and the emergence of highly transmissible variants such as Omicron, a booster shot is now part of staying up to date with your COVID-19 vaccination to protect against severe disease," the memo read, according to The Verge.

Apple did not immediately respond to a request for comment.

Many companies in the US have been strengthening their COVID-19 rules, mandating vaccination and delaying back-to-office plans as the Omicron variant increases infections across the country.

This week, Facebook parent Meta Platforms mandated COVID-19 booster shots for all workers returning to offices. It also delayed US office reopenings to March 28, from an earlier plan of Jan. 31.

Alphabet Inc's Google on Friday said it was temporarily mandating weekly COVID-19 tests for people entering its US offices.

A report by The Information said Amazon.com Inc has offered its US warehouse workers $40 to get a booster shot.

-reuters

Austria's vaccine board recommends 4th COVID jab

ZURICH - Austria should offer some healthcare staff and other key workers a fourth COVID-19 jab, the National Vaccination Board said in updated guidance published late on Thursday, citing risks from the fast-spreading Omicron variant of the coronavirus.

But it said there was not enough scientific data for it to recommend fourth shots be given more widely.

"In view of an imminent Omicron wave, (a fourth vaccination) can be offered in high-risk areas (e.g., exposed health care personnel) and in systemically critical areas from six months after the third vaccination," the board said.

Austria said on Wednesday it will tighten restrictions again from Dec. 27 to slow the spread of the Omicron variant.

In November, the government announced a fourth national lockdown and said it would make vaccinations compulsory for all Austrians, the first European Union country to do so.

While that three-week lockdown slashed daily COVID-19 infections from record levels, the country is bracing for another surge. Several hundred Omicron cases have been confirmed already.

In its updated guidelines, the National Vaccination Board said fourth COVID-19 shots could be given "off label" to groups in healthcare and other critical areas following medical consultation.

"There is still no evidence that this additional vaccination can prevent infections. However, it can be it can be assumed that serious illnesses can be prevented," it said. 

-reuters

Did vaccine inequality lead to the Omicron variant?

In October 2020, as scientists around the world raced to develop a vaccine to fight Covid-19, the leader of the World Health Organization warned against looming "vaccine nationalism".

In a video address, Tedros Adhanom Ghebreyesus said at the time that the only way to beat the pandemic was by making sure poorer countries had fair access to a vaccine.

"When we have an effective vaccine, we must also use it effectively," he said.

"And the best way to do that is to vaccinate some people in all countries rather than all people in some countries. Vaccine nationalism will prolong the pandemic, not shorten it."

Over a year later, vaccine inequality is undeniable. 

Rich nations like France and Japan have given at least one dose to over 75 percent of their populations.

In South Africa -- where the Omicron variant was first sequenced -- only a quarter of the population has been vaccinated. And is one of the highest inoculation rates on the continent.

But is vaccine inequality the reason behind Omicron's emergence?

French experts tasked with informing their government's pandemic response say Omicron likely came from a patient with a depressed immune system and is the result of a long line of mutations that accumulated during a chronic infection.

But wherever it came from, its spread would have been "slower, the higher the immunity of the surrounding population," Arnaud Fontanet, scientific advisory board member and epidemiologist at the Pasteur Institute, told AFP.

"You can imagine that the growth of the virus during uncontrolled epidemics creates more opportunities for variants to emerge," he said. 

- 'Shock the world' -

"I would like for this new worry to shock the world into realising the importance of vaccinating people on a global scale," Fontanet said.

"The planet will only be safe when we achieve a level of global immunity that significantly limits the spread and opportunities for new variants to emerge," he said.

The WHO sounded the alarm on vaccine inequality again in September when countries with plenty of resources began eyeing booster shots for vaccinated adults and others considered vaccines for children.

Speaking from WHO's headquarters in Geneva, Tedros called on countries to avoid giving out extra Covid jabs until the end of the year, pointing to the millions worldwide who have yet to receive a single dose.

"I will not stay silent when the companies and countries that control the global supply of vaccines think the world's poor should be satisfied with leftovers," he said.

A global vaccine-sharing system called Covax, led by WHO and the Gavi vaccine alliance among others, is meant to provide 92 low- and middle-income countries with jabs financed by rich states.

Covax says it has succeeded in administering 500 million doses in 144 countries and territories, and on Monday, Chinese president Xi Jinping promised a billion vaccine doses to Africa through donations or subsidies for local production.

But in a joint statement on Monday, the African Vaccine Acquisition Trust, the Africa Centres for Disease Control and Prevention and Covax said the quality of donations needs to improve. 

"The majority of the donations to-date have been ad hoc, provided with little notice and short shelf lives," they said. 

"This has made it extremely challenging for countries to plan vaccination campaigns and increase absorptive capacity."

Fontanet agrees.

"Vaccinating the world is not only a question of doses," he says.

"We have to support fragile health systems and work to persuade people to get the jabs."

- 'Follow the science' -

Now that Omicron has been identified, countries are taking measures to prevent its spread by banning flights from Southern Africa where it seems to have originated. 

Japan and Israel are closing their borders.

But epidemiologists say these sweeping gestures are beside the point.

"If you're worried about your risk from omicron, get vaccinated if you aren't already," US virologist Angela Rasmussen tweeted on Sunday. 

"Continue to layer other precautions. And more than anything, follow the science and advocate for collaborative global health. Travel bans won't do [expletive]. Vaccines and global health equity WILL."

Agence France-Presse 

Unvaccinated NBA players to face extensive COVID-19 curbs

NBA players who are not vaccinated against COVID-19 will have to comply with a long list of restrictions to take part in the upcoming season, according to a memo obtained by Reuters.

The National Basketball Association's tentative protocols released to teams on Tuesday showed vaccinated players will only be tested if they show coronavirus symptoms or are a close contact of a positive case.

However, unvaccinated players will have to undergo daily testing prior to entering a team facility, participating in team activities or interacting with players and coaches.

The protocols outlined in the memo are pending agreement between the league and the National Basketball Players Association (NBPA).

The NBPA did not immediately respond to a request for comment.

The 2021-2022 season is set to begin on Oct. 19 amid continuing concerns over the highly contagious delta variant of the novel coronavirus that has hit those who are unvaccinated particularly hard.

A handful of high-profile players, including Brooklyn Nets' Kyrie Irving and Washington Wizards Bradley Beal, have publicly refused to receive the shots, while some have repeated claims about the vaccine shown to be false by medical professionals.

"It’s untrue," the nation's top infectious disease expert Anthony Fauci told the Hugh Hewitt syndicated radio show on Wednesday referring to claims that the COVID-19 vaccine is dangerous or could hurt those who receive it.

"Although I do respect people’s individual rights... when you’re dealing with a deadly pandemic, you’ve got to also understand your responsibility to the society within which you live."

Among U.S. adults, 11% - or roughly 23 million people - have said they do not want the vaccine, do not plan to get it and that there was nothing that would encourage them to do so, according to a Reuters/Ipsos poll conducted in August.

'BEST SUITED'

Four-time NBA champion LeBron James of the Los Angeles Lakers said he decided to get the vaccine after initially being sceptical but stopped short of widely encouraging the jabs.

"I don't talk about other people and what they should do," James said. "I don't think I personally should get involved in what other people do for their bodies and livelihoods ... I felt like it was best suited for me and my family and my friends."

In July, NBA Players Association executive director Michele Roberts told Yahoo Sports that vaccination was not mandatory but 90% of players had already received their shots.

"The situation is obviously we would like to see essentially all of the players for the general safety to get vaccinated," Fauci told MSNBC in an interview on Wednesday.

Under the NBA draft rules circulated, the league would not allow unvaccinated players to dine in the same room as other players and they must also be given a locker as far away as possible from other players.

Unvaccinated players will also have to remain at the team hotel during road trips, outside game time except for team and essential activities.

With strict vaccination requirements in some local markets, including New York City and San Francisco, players could risk losing pay if they are unable to compete.

"Any player who elects not to comply with local vaccination mandates will not be paid for games that he misses," said league spokesman Mike Bass.

Damian Lillard, a Portland Trail Blazer who won a gold medal as part of Team USA at the Tokyo Olympics, this week said he got the COVID-19 vaccine just as he had other immunizations growing up, noting some of his relatives had died from COVID.

"I'm just not going to put their health or their lives in danger," he told reporters. "It's pretty simple, actually." 

(Reporting by Manasi Pathak in Bengaluru and Amy Tennery in New York, additional reporting by Susan Heavey; Editing by Peter Rutherford and Ken Ferris )

-reuters

US pharmacist jailed for 3 years after tampering with COVID-19 vaccines

WASHINGTON - A US pharmacist has been jailed for 3 years after pleading guilty to tampering with hundreds of Moderna coronavirus vaccines, the Justice Department said Tuesday.

Steven R. Brandenburg, 46, "purposefully removed" vaccine vials from their refrigerator unit even though they must be stored at a certain temperature until used, court documents said.

The pharmacist was also ordered to pay $83,800 in compensation to the Wisconsin hospital where he worked.

He removed the vials on 2 overnight shifts in December, leaving them outside for hours before returning them to be used on recipients the following day.

A total of 57 people received vaccines with the vials that Brandenburg had tampered with, the Justice Department statement said.

"The purposeful attempt to spoil vaccine doses during a national public health emergency is a serious crime," said Brian Boynton, acting assistant attorney general of the department's Civil Division.

Brandenburg had expressed skeptical views about vaccines and specifically the Moderna vaccine, according to his plea agreement.

Moderna vaccines must be stored at standard refrigerator temperatures.

More than 124 million doses of the Moderna vaccine have been administered in the US.

The 2-shot regime is around 90 percent effective against symptomatic COVID-19 and 95 percent effective against severe disease.

Agence France-Presse

Raging virus, few shots. How Brazil missed its chance to secure COVID-19 vaccines

RIO DE JANEIRO — Weeks after other Latin American countries began inoculating their citizens against coronavirus, Brazil finally administered its first shot on Jan. 17 using China's Sinovac Biotech Ltd vaccine.

With efficacy of just over 50% - barely above Brazil's threshold for regulatory approval - the Chinese shot was not the government's first choice. But for now, there is little else available.

The country's principle strategy - to manufacture 100 million doses of the AstraZeneca PLC vaccine locally - has been plagued by repeated delays. That effort isn't expected to yield a finished product until March at the earliest. 

AstraZeneca last week sent 2 million emergency doses to help Brazil get started. Meanwhile, Brazil's Health Ministry has yet to sign deals with other vaccine makers.

The delays leave Brazil's 210 million residents vulnerable to one of the worst coronavirus outbreaks on the planet. Brazil has tallied more than 218,000 COVID-19 fatalities, second only to the United States, and vaccinated less than 0.5% of its population.

Brazil's vaccine rollout is just the latest misstep by its Health Ministry, which President Jair Bolsonaro has stocked with active-duty and retired military men with little public health experience. 

Those newcomers failed to grasp how quickly they needed to move to secure supplies amid heated global competition, and the importance of hedging their bets by striking deals with multiple manufacturers, according to interviews with more than a dozen current and former officials, pharmaceutical executives, diplomats and public health experts.

The ministry's hesitance led to a missed opportunity back in August to order 70 million doses of a vaccine made by Pfizer Inc and BioNTech SE, with delivery starting in December, Pfizer said in a Jan. 7 statement.

Reuters also viewed an internal Health Ministry WhatsApp chat log, containing thousands of messages exchanged between senior officials last year as the global race for vaccines was heating up. The messages reveal that the new leadership team prioritized hydroxychloroquine and its cousin chloroquine, anti-malarial drugs championed by Bolsonaro as COVID-19 treatments despite little scientific evidence that they work.

"There was not sufficient focus on the vaccines, and a lack of technical vision," former Health Minister Nelson Teich told Reuters in an interview. Teich resigned in May in a disagreement with Bolsonaro over the hydroxychloroquine strategy.

Reuters sent a detailed list of questions for this story to the president's office, which directed queries to the Health Ministry. The ministry did not respond.

Bolsonaro - who contracted the coronavirus last year and says he won't take any COVID-19 shot - has defended his government's vaccine rollout. "With respect, nobody would do better than my government is doing," he said in a Jan. 15 television interview.

While many nations have struggled to obtain vaccines as manufacturers strive to meet global demand, Brazil was better positioned than many. It has a long history of successful inoculation drives, and its state-funded production facilities can churn out vaccines at scale.

The federal government squandered those advantages, said Marcia Castro, a native Brazilian and professor at the Harvard T.H. Chan School of Public Health in Boston.

"It's a succession of errors that began from the start of the pandemic," she said. "And sadly, we're measuring those mistakes in the number of deaths."

HYDROXYCHLOROQUINE OBSESSION

The AstraZeneca shot was supposed to be the main pillar of Brazil's inoculation plan. According to a person involved in the deal, the Cambridge, England-based firm started talking to the Health Ministry about buying its vaccine around early June.

By then, Teich, the former health minister, was gone, replaced by Eduardo Pazuello, an Army general with no medical background. He quickly surrounded himself with other military men.

Negotiations with a ministry in upheaval were challenging, said the person familiar with the talks.

"There were no decisions being driven from the top," the person said, referring to Bolsonaro and the new ministry leadership.

The new officials were betting on hydroxychloroquine to mitigate Brazil's pandemic, months of internal ministry WhatsApp chats viewed by Reuters revealed. Vaccines were mentioned infrequently in the chats, and at times with skepticism.

For example, on June 12, just days after being named deputy health minister, Elcio Franco, a retired Army colonel, alerted colleagues to a magazine article featuring AstraZeneca's top Brazilian executive discussing the company's vaccine. Franco expressed surprise that anyone might volunteer to participate in a vaccine trial.

"Who would be a guinea pig?" Franco wrote to his colleagues.

Franco did, however, express confidence in hydroxychloroquine and chloroquine.

In June, COVID-19 deaths per day were reaching new highs in Brazil, official data showed. Franco claimed the opposite was true.

"Death rates are dropping dramatically due to Bolsonaro's treatment protocol," he posted to the internal WhatsApp group on June 15. "Chloroquine is reversing the situation."

Franco did not respond to requests for comment through the Health Ministry or his LinkedIn account.

Brazil is now dealing with another surge of infections that's pushing hospitals to the breaking point in several cities.

The Health Ministry has doubled down on anti-malarials. It publicly has urged infected people to take them soon after the onset of symptoms, and this month it sent 120,000 hydroxychloroquine pills to the badly hit northern state of Amazonas.

 ASTRAZENECA TALKS

The person involved in the AstraZeneca talks said the Health Ministry's leadership didn't appear to grasp how quickly they'd need to act to secure a portion of the company's limited supply.

In an initial meeting around the start of June, Pazuello, the new chief, showed interest in buying the vaccine, "and then got up and left the room," the person said. "He didn't come to future calls."

Pazuello did not respond to requests for comment.

During ministry talks, AstraZeneca officials stressed the need for Brazil to make a financial commitment to guarantee delivery, the source said.

Ministry newcomers were still mastering government red tape, slowing the transaction, three people familiar with the situation said. The officials also proceeded cautiously to avoid any perception that they stood to profit from an unproven vaccine, following public graft scandals that had upended the country in recent years, the people said.

"They fear that people will assume there were kickbacks involved and their opponents will use it as a reason to launch an investigation," the source said.

Meanwhile, Britain, the European Union and the United States signed large deals with AstraZeneca.

With Brazil's Health Ministry dithering, AstraZeneca reached out to officials in other parts of government to help unlock funding, said the person involved in the negotiations.

AstraZeneca did not respond to requests for comment.

On June 27, Brazil announced it had signed a $127 million agreement to start producing AstraZeneca's vaccine at Rio de Janeiro's federally funded Fiocruz Institute. Franco, the deputy health minister, said in late June that Brazil would initially produce some 30 million doses of the vaccine, half by December 2020, the rest in January 2021.

But Fiocruz has yet to manufacture a single dose because it lacks the active ingredient needed to make the vaccine. The first shipment of that Chinese-made material is now delayed until around Feb. 8, Fiocruz said this week, without giving a reason. Fiocruz had previously predicted it would produce finished doses by March. It will update that forecast once the ingredient arrives, the statement said.

Yang Wanming, China's ambassador to Brazil, said in a Tuesday press conference that "technical" obstacles were holding up the shipment. He did not elaborate.

With its timetable slipping, the Health Ministry in late December appealed to AstraZeneca, which was able to source 2 million ready-to-use shots from India. Those doses, which arrived in Brazil on Jan. 22, will immunize just 0.5% of Brazil's population.

PFIZER FAILURE

Negotiations with Pfizer, meanwhile, have turned testy. The Health Ministry publicly has chastised the company for demanding Brazil sign a waiver shielding it from any potential liability regarding its vaccine.

Pfizer says many countries have signed the waiver; it blames Brazil's government for dragging its feet. In a January statement, the company said it began talks in June with the Health Ministry, which it said passed on Pfizer's August 15 offer to supply 70 million doses.

With those negotiations bogged down, Brazil's government has turned to the Sinovac shot.

Bolsonaro, a vocal China critic, had vowed never to purchase the Chinese vaccine. On Jan. 13, he delighted in pointing out to supporters that the vaccine's Brazilian trials, conducted at São Paulo's Butantan Institute, a public biomedical research center, had shown a disappointing efficacy rate of 50.4%.

But with few options left, the Health Ministry recently announced a deal to purchase up to 100 million doses from Butantan.

On Jan. 18, Bolsonaro struck a more conciliatory tone. Sinovac's shot, he told supporters, was "Brazil's vaccine."

-reuters

Singapore gets Asia's first batch of Pfizer's COVID-19 vaccine

SINGAPORE - Singapore received its first batch of Pfizer-BioNTech's COVID-19 vaccine on Monday, according to its flag carrier, ahead of a rollout in the city-state that health officials have said could be as soon as two-three weeks away.

Singapore Airlines, which carried the vaccines on board one of its freighters from Belgium, did not specify the size of the batch.

Singapore is the first Asian country to receive the Pfizer-BioNTech shots after it said last week that it had approved the companies' vaccine.

Prime Minister Lee Hsien Loong, 68, has said he would be among the early recipients of the vaccine in the nation of 5.7 million people, which has one of the lowest coronavirus fatality rates globally.

"Delighted to see the first shipment of vaccines arrive in Singapore," Lee posted on Facebook on Monday, adding that the authorities will announce details of a rollout in due course.

He reiterated that the vaccination will be voluntary, and that he encouraged Singaporeans to take it.

The government plans to first administer the vaccine to healthcare workers and the elderly. Health ministry official Kenneth Mak had last week said the first jabs could be given "within the next two to three weeks" if safely delivered.

Singapore has kept new local infections to almost zero each day in recent months and will further ease restrictions next week.

It has signed advanced purchase agreements and made early down-payments on several vaccine candidates including those being developed by Moderna and Sinovac, setting aside more than S$1 billion ($746.16 million) for shots.

Most of the city-state's more than 58,000 coronavirus cases occurred in cramped migrant worker dormitories, but there are some concerns about asymptomatic carriers and undetected transmission taking place.

The government said on Saturday it was investigating whether 13 travellers who tested positive at a five-star hotel in November may have been infected there during their mandatory quarantine, rather than prior to their arrival in the country.

-reuters-

UK warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions

LONDON - Britain's medicine regulator has advised that people with a history of significant allergic reactions do not get Pfizer-BioNTech's COVID-19 vaccine after two people reported adverse effects on the first day of rollout.

Britain began mass vaccinating its population on Tuesday in a global drive that poses one of the biggest logistical challenges in peacetime history, starting with the elderly and frontline workers

National Health Service medical director Stephen Powis said the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine.

"As is common with new vaccines the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination, after two people with a history of significant allergic reactions responded adversely yesterday," Powis said.

"Both are recovering well.”

The MHRA said it would seek further information, and Pfizer and BioNTech said they were supporting the MHRA's investigation.

The Medicines and Healthcare products Regulatory Agency (MHRA) was the first in the world to approve the vaccine, developed by Germany's BioNTech and Pfizer, last week, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

"Last evening, we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn't a feature," MHRA Chief Executive June Raine told lawmakers.

Pfizer has said people with a history of severe adverse allergic reactions were excluded from their late stage trials.

The FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine's efficacy and safety data met its expectations for authorization.

That briefing document said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, Professor of Experimental Medicine at Imperial College London, said was a very small number.

"The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well," he said. 

-Reuters

EU secures 160 million doses of Moderna's COVID-19 vaccine

BRUSSELS - The European Union has struck a deal for up to 160 million doses of U.S. firm Moderna's COVID-19 vaccine candidate, the head of the European Commission said on Tuesday, taking the EU's potential stock of COVID-19 shots to nearly 2 billion.

Last week, Moderna said its experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial.

"I am happy to announce that tomorrow we will approve a new contract to secure another COVID-19 vaccine," Ursula von der Leyen said, adding the deal "allows us to buy up to 160 million doses of a vaccine produced by Moderna."

Actual purchases will be carried out by EU governments if the vaccine is approved by the EU's drug regulator.

The delivery timeline is unknown. The doses would be enough to vaccinate 80 million people as the vaccine is expected to be administered in two doses.

In August the EU's executive Commission, which co-leads talks with vaccine makers on behalf of member states, said it had held preliminary talks with Moderna over a deal for 80 million doses and an option for 80 million more.

The terms of the contract have not been disclosed.

An EU official involved in the talks told Reuters last week the EU was seeking a price below $25 per dose for Moderna's vaccine..

But Moderna Chief Executive Stephane Bancel said on Sunday the company would charge governments between $25 and $37 per dose, depending on the amount ordered.

A spokesman for the Commission declined to comment on pricing.

It is the sixth supply deal the EU has negotiated with COVID-19 vaccine makers and takes the total number of doses secured by the bloc to 1.96 billion for its population of around 450 million.

Brussels has already struck deals with AstraZeneca, Pfizer-BioNTech, Sanofi-GSK, Johnson & Johnson and CureVac.

It is also in talks to buy U.S. firm Novavax's potential COVID-19 vaccine. 

-reuters-

UK scientists immunize hundreds with coronavirus vaccine

LONDON (AP) — Scientists at Imperial College London say they are immunizing hundreds of people with an experimental coronavirus vaccine in an early trial after seeing no worrying safety problems in a small number vaccinated so far.

Dr. Robin Shattock, a professor at the college, told The Associated Press that he and colleagues had just finished a very slow and arduous process of testing the vaccine at a low dose in the initial participants and would now expand the trial to about 300 people, including some over age 75.

“It’s well tolerated. There aren’t any side effects,” he said, adding it was still very early in the study. Shattock, who is leading the vaccine research at Imperial, said he hopes to have enough safety data to start inoculating several thousand people in October.
Since COVID-19 infections have dropped dramatically in Britain, making it difficult to determine whether or not the vaccine works, Shattock said he and his colleagues are also looking to test their vaccine elsewhere.

“We’re looking very carefully at the pandemic, at the numbers where the hot spots are and talking to collaborators that have the facilities to do these kinds of studies,” he said.

The Imperial vaccine uses synthetic strands of genetic code based on the virus. Once injected into a muscle, the body’s own cells are instructed to make copies of a spiky protein on the coronavirus. That should in turn trigger an immune response so the body can fight off any future COVID-19 infection.

Earlier this week, the world’s biggest coronavirus vaccine study started in the United States, with the first of 30,000 planned volunteers getting immunized with shots created by the U.S. National Institutes of Health and Moderna Inc.

Several other vaccines made by China and by Britain’s Oxford University, based on different vaccine technologies, began smaller final-stage tests in Brazil and other hard-hit countries earlier this month.

The World Health Organization has said multiple vaccine approaches are necessary for COVID-19, noting that the usual success rate for vaccine development is about 10%.

Shattock said there were numerous coronavirus vaccines now in clinical trials, and he predicted that at least some of them would prove to be effective.

“We have 20 vaccines in clinical trials, (so) we can be pretty confident that at least two of those will work,” he said. “It really depends on how strong the immune response needs to be to provide protection.”

Shattock said he was optimistic the Imperial vaccine would work, but must await the scientific data from the trial.

“I’m just going to hold my breath and wait to see,” he said.

-Associated Press

UK coronavirus vaccine prompts immune response in early test

LONDON (AP) — Scientists at Oxford University say their experimental coronavirus vaccine has been shown in an early trial to prompt a protective immune response in hundreds of people who got the shot.

British researchers first began testing the vaccine in April in about 1,000 people, half of whom got the experimental vaccine. Such early trials are designed to evaluate safety and see what kind of immune response was provoked, but can’t tell if the vaccine truly protects.

In research published Monday in the journal Lancet, scientists said that they found their experimental COVID-19 vaccine produced a dual immune response in people aged 18 to 55 that lasted at least two months after they were immunized.

“We are seeing good immune response in almost everybody,” said Dr. Adrian Hill, director of the Jenner Institute at Oxford University. “What this vaccine does particularly well is trigger both arms of the immune system,” he said.

Hill said that neutralizing antibodies are produced — molecules which are key to blocking infection. In addition, the vaccine also causes a reaction in the body’s T-cells, which help by destroying cells that have been taken over by the virus.

The experimental COVID-19 vaccine caused minor side effects like fever, chills and muscle pain more often than in those who got a control meningitis vaccine.

Hill said that larger trials evaluating the vaccine’s effectiveness, involving about 10,000 people in the U.K. as well as participants in South Africa and Brazil are still underway. Another trial is slated to start in the U.S. soon, aiming to enroll about 30,000 people.

How quickly scientists are able to determine the vaccine’s effectiveness will depend largely on how much more transmission there is, but Hill estimated that if there were enough data to prove the vaccine’s efficacy, immunization of some high-risk groups in Britain could begin in December.

He said the vaccine seemed to produce a comparable level of antibodies to those produced by people who recovered from a COVID-19 infection and hoped that the T-cell response would provide even more protection.

“There’s increasing evidence that having a T-cell response as well as antibodies could be very important in controlling COVID-19,” Hill said. He suggested the immune response might be boosted after a second dose; in a small number of people, their trial tested two doses administered about four weeks apart.

Hill said Oxford’s vaccine is designed to reduce disease and transmission. It uses a harmless virus — a chimpanzee cold virus, engineered so it can’t spread — to carry the coronavirus’ spike protein into the body, which should trigger an immune response.

Hill said Oxford has partnered with drugmaker AstraZeneca to produce their vaccine globally, and that the company has already committed to making 2 billion doses.

“Even 2 billion doses may not be enough,” he said, pointing to the ongoing surge of infections worldwide. “I think its going to be very difficult to control this pandemic without a vaccine.”

Hill said researchers were also considering conducting a “challenge” trial by the end of 2020, an ethically controversial test where participants would be deliberately infected with COVID-19 after being immunized to see if the vaccine is effective.

“This has been done before in 19 different infectious diseases to develop vaccines and drugs and is likely to happen for COVID-19 as well,” he said.

Numerous countries including Germany, France, the Netherlands, Italy, U.S. and the U.K. have all signed deals to receive hundreds of millions of doses of the Oxford vaccine — which has not yet been licensed — with the first deliveries scheduled for the fall.

Chinese researchers also published a study on their experimental COVID-19 vaccine in the Lancet on Monday, using a similar technique as the Oxford scientists. They reported that in their study of about 500 people, an immune response was detected in those who were immunized, although they couldn’t tell if people were protected from the disease because they weren’t exposed to COVID-19 afterwards.

CanSino Biologics’ vaccine is made similarly to Oxford’s except the Chinese shot is made with a human cold virus, and the study showed people whose bodies recognized it didn’t get as much of the presumed COVID-19 benefit. Still, China’s government already gave special approval for the military to use CanSino’s vaccine while it explores final-stage studies.

In an accompanying editorial, Naor Bar-Zeev and William Moss of the Johns Hopkins Bloomberg School of Public Health called both the Oxford and Chinese results “encouraging” but said further judgment should wait until the vaccine is tested on much bigger populations.

The World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, called for any eventual COVID-19 shots to be fairly distributed globally, saying it was up to political leaders to ensure the most vulnerable populations also get immunized.

“But one of the worrying patterns we see is some countries moving in the other direction,” he warned.

Britain announced Monday it had secured access to another 90 million experimental COVID-19 vaccines made by Pfizer and others, a move some campaigners warned could worsen a global scramble by rich countries to hoard the world’s limited supply of COVID-19 vaccines.

Last week, American researchers announced that the first COVID-19 vaccine tested there boosted people’s immune systems just as scientists had hoped and the shots will now enter the final phase of testing. That vaccine, developed by the National Institutes of Health and Moderna, produced the molecules key to blocking infection in volunteers who got it, at levels comparable to people who survived a COVID-19 infection.

The vaccine being developed by Pfizer also works to trigger a similar dual immune response as the Oxford shot. Pfizer and its German partner BioNTech also released an encouraging early report Monday.

Nearly two dozen potential vaccines are in various stages of human testing worldwide, with a handful entering necessary late-stage testing to prove effectiveness.

___

AP Medical Writer Lauran Neergaard in Alexandria, Virginia, and Jamey Keaten in Geneva, contributed to this report.

The Associated Press

Asian markets mostly higher on hopes for coronavirus vaccine

Shares were mostly higher in Asia on Wednesday as investors were encouraged by news that an experimental COVID-19 vaccine under development by Moderna and the U.S. National Institutes of Health revved up people’s immune systems just as desired.

Tokyo’s Nikkei 225 advanced 1.6% to 22,945.50, while the Kospi in South Korea added 0.9% to 2,201.96. In Australia, the S&P/ASX 200 added 1.7% to 6,039.50. Hong Kong’s Hang Seng was nearly unchanged at 25,476.31, while the Shanghai Composite Index slipped 0.5% to 3,397.63. Shares were mixed in Southeast Asia and rose in Taiwan.

The Bank of Japan kept its ultra-easy monetary stance unchanged as it wrapped up a policy meeting. It forecast that the economy would improve later in the year, assuming there is no major “second wave” of outbreaks of the new coronavirus.

But the central back acknowledged very high uncertainties over the outlook for the world’s third largest economy. The bank’s growth forecast for the year was downgraded to minus 5.7%- minus 4.5% from the earlier forecast of minus 5%-minus 3%.

The report also raised the issue of financial stability, noting that the “vulnerability of the financial system could increase,” said Marcel Thieliant of Capital Economics.

Investors are awaiting April-June economic growth data for China, which is due later in the week.

The focus for now was on news that scientists soon will begin a 30,000-person study to see if the experimental vaccine developed by Moderna and the NIH is strong enough to protect against the coronavirus.

News about the vaccine came after the end of trading for U.S. markets, where after another day of unsettled trading the S&P 500 rose 1.3% to 3,197.52. The Dow Jones Industrial Average added 2.1% to 26,642.59, lifted by gains for UnitedHealth Group and Caterpillar, among others.

Upbeat earnings news is helpful, “But the cherry on top has to be the positive virus vaccine update as optimism on the vaccine is more than a show stopper. Its the ultimate recession stopper,” Stephen Innes of AxiCorp said in a commentary.

“The positive coverage on a potential Covid-19 vaccine represents a rotating carousel of positive news that is overwhelming rising virus cases in the U.S.,” he said.

On Wall Street, big tech-oriented stocks lagged behind, holding the Nasdaq composite to a more modest gain of 0.9% to 10,488.58.

The earnings reporting season has kicked off with three of the nation’s biggest banks painting a mixed picture of how badly the coronavirus pandemic is ripping through their businesses.

Like the broader market, financial stocks drifted between gains and losses for much of the day before turning higher in the afternoon. JPMorgan Chase, Wells Fargo and Citigroup said they collectively set aside nearly $27 billion during the second quarter to cover loans potentially going bad due to the recession.

The yield on the 10-year Treasury held at 0.63% after rallying back from a morning dip on Tuesday to 0.60%. It tends to move with investors’ expectations of the economy and inflation.

Benchmark U.S. crude oil rose 10 cents to $40.39 per barrel in electronic trading on the New York Mercantile Exchange. It gained 19 cents to settle at $40.29 per barrel on Tuesday. Brent oil, the international standard, picked up 13 cents to $43.03 per barrel. It rose 18 cents to $42.90 a barrel in London.

In currency dealings, the dollar bought 107.27 Japanese yen, up from 107.23 yen late Tuesday. The euro also was almost unchanged, rising to $1.1406 from $1.1401.

Associated Press

Race for virus vaccine could leave some countries behind

LONDON (AP) — As the race intensifies for a vaccine against the new coronavirus, rich countries are rushing to place advance orders for the inevitably limited supply to guarantee their citizens get immunized first — leaving significant questions about whether developing countries will get any vaccines in time to save lives before the pandemic ends.

Earlier this month, the United Nations, the International Red Cross and Red Crescent, and others said it was a “moral imperative” that everyone have access to a “people’s vaccine.” But such grand declarations are unenforceable, and without a detailed strategy, the allocation of vaccines could be inequitable and extremely messy, said health experts.

“We have this beautiful picture of everyone getting the vaccine, but there is no road map on how to do it,” said Yuan Qiong Hu, a senior legal and policy adviser at Doctors Without Borders in Geneva. Few measures have been taken to resolve numerous problems for achieve fair distribution, she said.

In the past, Hu said, companies have often applied for patents for nearly every step of a vaccine’s development and production: from the biological material like cell lines used, to the preservative needed to stretch vaccine doses and even how the shots are administered.

“We can’t afford to face these multiple layers of private rights to create a ‘people’s vaccine,’” she said.

Speaking at a vaccine summit earlier this month that addressed the thorny issue of equitable distribution, Ghanaian President Nana Akufo-Addo agreed.

“Only a people’s vaccine with equality and solidarity at its core can protect all of humanity from the virus,” he said.

At a summit with African leaders on Wednesday, Chinese President Xi Jinping said countries in Africa would be “among the first to benefit” once a COVID-19 vaccine is developed and deployed in China, but no deals were announced to back up his promise.

Worldwide, about a dozen potential COVID-19 vaccines are in early stages of testing. While some could move into late-stage testing later this year if all goes well, it’s unlikely any would be licensed before early next year at the earliest. Still, numerous rich countries have already ordered some of these experimental shots and expect delivery even before they are granted marketing approval.

Britain and the U.S. have spent millions of dollars on various vaccine candidates, including one being developed by Oxford University and manufactured by AstraZeneca. In return, both countries are expected to get priority treatment; the British government declared that if the vaccine proves effective, the first 30 million doses would be earmarked for Britons.

Separately AstraZeneca signed an agreement to make at least 300 million doses available for the U.S., with the first batches delivered as early as October. In a briefing Tuesday, senior Trump administration officials said there will be a tiered system to determine who in America is offered the first vaccine doses. Tiers likely would include groups most at risk of severe disease and workers performing essential services.

Last week, the European Union moved to ensure its own supply. On Saturday, AstraZeneca struck a deal with a vaccines group forged by Germany, France, Italy and the Netherlands to secure 400 million doses by the end of the year.

Among several global efforts underway to try to ensure developing countries don’t get left behind is an “advance market commitment” from the vaccines alliance GAVI, whose CEO has warned countries about the dangers of vaccines not being available globally.

“Even if a few countries go ahead and have vaccines, if there are raging outbreaks in other places ... that is going to continue to threaten the world and the return to normality,” said Seth Berkley, the GAVI CEO.

GAVI and partners have inked a $750 million deal with AstraZeneca to supply 400 million doses by the end of 2020. The Anglo-Swedish pharma giant has also agreed to license its vaccine to India’s Serum Institute for the production of 1 billion doses.

Johnson & Johnson plans to make its coronavirus shot for poor countries at a not-for-profit price, because of the complexity of the technology and expertise needed, said the company’s chief scientific officer, Dr. Paul Stoffels. Likewise, AstraZeneca has pledged to make the vaccine available at no profit during the pandemic.

The World Health Organization and others have called for a COVID-19 “patents pool,” where intellectual property rights would be surrendered so pharmaceuticals could freely share data and technical knowledge. Numerous countries including Australia, Brazil, Canada and Germany have already begun revising their licensing laws to allow them to suspend intellectual property rights if authorities decide there is an overwhelming need given the pandemic.

But the response from the industry has been lukewarm.

Executives at Pfizer and some other major drug makers say they oppose suspending patent rights for potential COVID-19 vaccines.

Health officials worry what that might mean for divvying up supplies of a vaccine arguably needed by every country on the planet.

“We can’t just rely on goodwill to ensure access,” said Arzoo Ahmed, of Britain’s Nuffield Council on Bioethics, noting that precedents of how innovative drugs have been distributed are not encouraging. “With HIV/AIDS, it took 10 years for the drugs to reach people in lower-income countries.”

African nations have already been at the back of the line for medical supplies in the pandemic and “it will be worse if a vaccine is found,” UNAIDS chief Winnie Byanyima told reporters Thursday. “We can’t afford to be in the back of the queue.”

Other experts pointed out that there are billions of taxpayer dollars devoted to every stage of vaccine development, but little oversight over how the funds are spent and few guarantees the inoculations will get to those who need them most.

“We don’t know what the process will look like or how transparent it will be,” said Suerie Moon, co-director of the Global Health Centre at the Graduate Institute Geneva.

The World Health Organization is currently working on developing an “allocation framework” for how coronavirus vaccines should be given out, said Dr. Soumya Swaminathan, the U.N. health agency’s chief scientist. But this guidance would not be binding.

Swaminathan said she hoped there might be 2 billion doses available for vulnerable and priority health workers globally by the end of next year and that WHO would propose how they might be distributed.

“Countries need to agree and come to a consensus,” she said. “That’s the only way this can work.”

___

Larson reported from Washington. Associated Press writers Danica Kirka in London, Lauran Neergaard in Alexandria, Virginia, Linda A. Johnson in Fairless Hills, Pennsylvania, and Cara Anna in Johannesburg contributed to this report.

The Associated Press 

Vaccine could virtually eliminate cervical cancer – study

PARIS, France – The rapid scale-up of the human papillomavirus (HPV) vaccine could virtually eliminate cervical cancer in a handful of rich countries within three decades, and in most other nations by century’s end, researchers said Wednesday.

Without screening and HPV vaccination, more than 44 million women will likely be diagnosed with the disease over the next 50 years, they reported in The Lancet Oncology, a medical journal.

Two thirds of these cases — and an estimated 15 million deaths — would occur in low- and medium-income countries.


By contrast, the rapid deployment starting in 2020 of screening and vaccination could prevent more than 13 million cervical cancers by mid-century worldwide, and lower the number of cases to below four-per-100,000 women, the study found.

“This is a potential threshold for considering cervical cancer to be eliminated as a major public health problem,” the authors said in a statement.

Earlier this month, the World Health Organization (WHO) reported 570,000 new cases worldwide in 2018, making it the fourth most common cancer for women after breast, colon and lung cancer.

The disease claims the lives of more than 300,000 women every year, mostly in lower income nations.

“Despite the enormity of the problem, our findings suggest that global elimination is within reach,” said lead author Karen Canfell, a professor at the Cancer Council New South Wales, in Sydney.

Achieving that goal, however, depends on “both high coverage of HPV vaccination and cervical screening,” she added.

Transmitted sexually, HPV is extremely common and includes more than 100 types of virus, at least 14 of them cancer-causing.

The viruses have also been linked to cancers of the anus, vulva, vagina and penis.

It takes 15 to 20 years for cervical cancer to develop in women with normal immune systems. If the immune system is weak or compromised — by HIV infection, for example — the cancer can develop far more quickly.

Clinical trials have shown that HPV vaccines are safe and effective against the two HPV strains — types 16 and 18 — responsible for 70 percent of cervical cancer cases.

The study’s projections presume the vaccination of 80 percent of girls 12 to 15 years old starting in 2020, and that at least 70 percent of women undergo screening twice in their lifetime.

This would push the prevalence of the disease below the bar of 4/100,000 women in countries such as the United States, Canada, Britain and France by 2059, and in mid-income countries such as Brazil and China by 2069, the authors calculate. /cbb

source: technology.inquirer.net

Dengue vaccine in sight, after 70 years

LONDON - One of the grimmest legacies of the war in the Pacific is still being fought 70 years on, but a victory over dengue, the intensely painful "breakbone fever" which that conflict helped spread around the world, may be in sight.

The U.S. Army, which like its Japanese enemy lost thousands of men to the mosquito-borne disease in the 1940s, has piled resources into defeating the tropical killer. But it may be about to see the battle to develop the first vaccine won not in the United States but by French drug company Sanofi.

The Paris-based firm hopes for positive results in September from a key trial among children in Thailand that would set it on course to market a shot in 2015 which would prevent an estimated 100 million cases of dengue infection each year. Of 20,000 annual deaths, many are of children.

For Sanofi, which has invested 350 million euros (283.3 million pounds) in a new French factory to make the three-dose vaccine, it could mean a billion euros in yearly sales as half the world is exposed to the disease, notably in fast-expanding tropical cities from Rio and Mexico to Manila and Mumbai.

But like British rival GlaxoSmithKline, whose new malaria shot has shown promise against another mosquito-carried scourge, Sanofi is also preparing for pressure to make its drug accessible to billions too poor to pay the likely market price.

It has been a long wait. Identified in local outbreaks in the Americas, Africa and Asia since the 18th century - and noted as a serious military hindrance by U.S. generals in their 1898 war against Spain in Cuba and the Philippines - dengue spread to global pandemic proportions in part due to the massive movements of armies through the Pacific theatre in World War Two.

That conflict, in which some 90,000 American troops were put in hospital by dengue, prompted the first efforts to develop a vaccine, as U.S. and Japanese scientists isolated the virus spread by the bite of the Aedes aegypti mosquito. But the disease, which can cause intense joint and muscle pain, has gone on sapping the health of troops, from Vietnam to Somalia and Haiti, and made lives miserable for millions of civilians.

In the past 50 years there has been a thirty-fold jump in cases. The World Health Organization officially puts infections at 50 to 100 million a year, though many experts think this assessment from the 1990s badly under-estimates the disease. Most patients survive but the disease is estimated to kill about 20,000 every year, many of these children less able to fight it off.

Tale of two vaccines

The U.S. Army's quest for a vaccine had most recently been pursued in partnership with GlaxoSmithKline. But Sanofi now seems closest to offering a viable treatment. And, unlike GSK's malaria injection designed for African babies, it promises to be the commercial blockbuster the French firm needs to refresh a portfolio weakened by expiring patents.

Its estimate of over 1 billion euros in annual sales - Sanofi's 2011 turnover was 33.4 billion euros - assumes that it is added to routine immunization schedules in Latin America and Asia and is also adopted by travellers from farther afield and by military medics in the United States and Europe.

Meeting that sales potential, while getting the vaccine to hundreds of millions who need it across the tropics, will require a careful balancing act on pricing and supply of a product that has yet to be given a commercial brand name.

Orin Levine, executive director of the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health, says the new vaccine is a potential breakthrough but warned its roll-out may not be straightforward.

First up, the vaccine needs to be given in three instalments over the course of a year in order to counter the threat from four different types of dengue virus, none of which confers immunity for the others.

"There are going to be some challenges," says Levine. "There's really good economic potential from this vaccine but I think it may take a ramp-up of three to five years."

Sanofi's bet

In an ideal world, healthcare experts would like a single-dose or, at most, a two-dose vaccine for mass immunization.

A simpler regimen would also be better for travellers, although Pascal Barollier of Sanofi Pasteur, Sanofi's vaccine arm, says many users will be people making regular trips to see families in Latin America or Asia with time to plan ahead. The military, too, often has lead time for troop movements.

In any case, Sanofi is putting its money where its mouth is by spending 350 million euros on a new dengue vaccine factory near Lyon, which is already in test production.

It is a substantial gamble, since Sanofi will only learn whether the vaccine really works when it analyzes data from a first study of its efficacy on 4,000 Thai children.

Results from that clinical study, in what is known as the Phase IIb of the international standard three-stage process of assessment, are expected in the third quarter - most likely September. They will also be presented for scientific scrutiny at the annual meeting of the American Society of Tropical Medicine and Hygiene in Atlanta in November.

If the data is good, Sanofi will file for market approval in countries where dengue is endemic like Australia, Malaysia, Singapore, Thailand and Mexico in 2013, suggesting a regulatory green light in 2014 and commercial launch in early 2015.

Submissions in other countries and for the travellers market would follow in 2014 and 2015.

Looking good

Early tests have shown a balanced immune response against all four dengue types and Duane Gubler of the Duke-N.U.S. Graduate Medical School, who has researched dengue for four decades, is optimistic.

"Everything they've done so far looks very good," he says. "I think it will be a much better vaccine than malaria."

He expects Sanofi's vaccine will show an efficacy rate of at least 75 to 80 percent, well above the 50 percent or so seen with GSK's malaria shot, which faces the added technical problem of fighting a complex parasite rather than a virus.

The efficacy rate refers to the reduction in the prevalence of subsequent infection among those vaccinated.

Despite both being transmitted by mosquitoes, dengue and malaria are notably different enemies.

Malaria, which is carried by a different mosquito, typically attacks rural populations living near swamps. Dengue, by contrast, has adapted to life in the city and is one of the winners of mankind's accelerating rush to urbanize.

The number of people living in urban areas is projected to rise to 6.3 billion by 2050 from 3.4 billion today, leading to more mega-cities with poor sanitation where dengue and other diseases can thrive, according to a study in The Lancet medical journal last week.

Globalization has also brought cases of dengue into southern Europe and the United States, particularly Texas and Florida, although Gubler believes higher living standards mean it is not likely to take off in these regions.

Pricing decision

For the middle classes of Latin America and Asia, an out-of-pocket purchase of a dengue vaccine probably seems affordable and worthwhile, especially for their children. Yet dengue takes its biggest toll among the poor, who lack money for immunization and are also less likely to get medical help when the disease leads to potentially deadly haemorrhagic fever.

Getting the vaccine to them will need the involvement of international agencies like the GAVI Alliance, which provides routine childhood immunisations in poor countries with funds granted by public and private donors.

Nina Schwalbe, GAVI's managing director for policy and performance, says she is monitoring the dengue vaccine programme closely but needs hard evidence that it offers value for money, based on public health impact, efficacy and price.

Sanofi is not ready to set a price before it sees the full clinical trial results and has a clearer sense of vaccine yields at its factory. But the drug maker will embrace "tiered pricing" to make the product affordable, Barollier at the company said.

That has not stopped the guessing.

"I would expect, for middle-income countries, they would be looking at prices similar to those of other new vaccines - for example HPV (human papillomavirus), pneumococcal and rotavirus vaccines - which sell for $15 to $70 per course in countries like Brazil, South Africa, Venezuela and Thailand," said IVAC's Levine.

Setting the price will be a test for Sanofi Chief Executive Chris Viehbacher. He reckons his vaccine is about five years ahead of any others and he knows he has a major opportunity to boost his company's reputation by getting the roll-out right.

With no specific drugs to treat or prevent dengue - in contrast to malaria - the world needs a success. Likewise, Viehbacher's shareholders, who have seen the company lose top-selling drugs as patents expire, need a commercial winner.

They will be watching closely those results from Thailand in September. — Reuters

source: gmanetwork.com