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AstraZeneca: US data shows vaccine effective for all ages

Associated Press

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AstraZeneca US data shows vaccine effective for all ages

AstraZeneca’s COVID-19 vaccine provided strong protection against sickness and eliminated hospitalizations and deaths from the disease across all age groups in a late-stage study in the United States, the company announced Monday.

AstraZeneca said its experts did not identify any safety concerns related to the vaccine, including finding no increased risk of rare blood clots identified in Europe.

Although AstraZeneca’s vaccine has been authorized in more than 50 countries, it has not yet been given the green light in the U.S. — and has struggled to gain public trust amid a troubled rollout. The study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots.

In a statement, AstraZeneca said its COVID-19 vaccine was 79% effective at preventing symptomatic COVID-19 and was 100% effective in stopping severe disease and hospitalization, though it has not yet published full data. Investigators said the vaccine worked across all ages, including older people — something experts wanted better data on. Two doses of the AstraZeneca vaccine were given to people four weeks apart.

“These findings reconfirm previous results observed,” said Ann Falsey, of the University of Rochester School of Medicine, who helped lead the trial. “It’s exciting to see similar efficacy results in people over 65 for the first time.”

The AstraZeneca shot is a pillar of a U.N.-backed project known as COVAX that aims to get COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts.

Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring but that more details were needed to back up AstraZeneca’s claim that the vaccine was completely effective at preventing severe disease and hospitalization.

”It would be good to know how many severe cases occurred in the control group and so what the confidence intervals are for this 100% figure,” said Hunter, who was not connected to the study. “But this should add confidence that the vaccine is doing what it is most needed for.”

The early findings from the U.S. study are just one set of information AstraZeneca must submit to the Food and Drug Administration. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use of the vaccine. In the past, the time between a company revealing efficacy data and a shot being authorized in the U.S. has been about a month.

Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data is important for two reasons: The findings will reassure the FDA, which is reluctant to rely on data obtained outside the United States, but they could also boost confidence more broadly in the shot.

“The benefits of these results will mainly be for the rest of the world where confidence in the AZ (AstraZeneca) vaccine has been eroded, largely by political and media comment,” he said.

Scientists had hoped the U.S. study would clear up some of the confusion about just how well the shots really work, particularly in older people. Previous research suggested the vaccine was effective in younger populations, but there was no solid data proving its efficacy in those over 65, often those most vulnerable to COVID-19.

Britain first authorized the vaccine based on partial results from testing in the United Kingdom, Brazil and South Africa that suggested the shots were about 70% effective. But those results were clouded by a manufacturing mistake that led some participants to get just a half dose in their first shot — an error the researchers didn’t immediately acknowledge.

Then came more questions, about how well the vaccine protected older adults and how long to wait before the second dose. Some European countries including Germany, France and Belgium initially withheld the shot from older adults and only reversed their decisions after new data suggested it was offering seniors protection.

AstraZeneca’s vaccine development was rocky in the U.S., too. Last fall, the FDA suspended the company’s study for an unusual six weeks, as frustrated regulators sought information about some neurologic complaints reported in Britain; ultimately, there was no evidence the vaccine was to blame.

Last week, more than a dozen countries, mostly in Europe, temporarily suspended their use of the AstraZeneca shot after reports it was linked to rare blood clots — even as international health agencies insisted the benefits of the vaccine outweighed the risks. On Thursday, the European Medicines Agency concluded after an investigation that the vaccine did not raise the overall risk of blood clots, but could not rule out that it was connected to two very rare types of clots. It recommended adding a warning about these cases to the vaccine’s leaflet.

It’s not unheard of for such rare problems to crop up as vaccines are rolled out since trials typically look at tens of thousands of people, and some issues are only seen once the shot is used in millions of people.

France, Germany, Italy and other countries subsequently resumed their use of the shot on Friday, with senior politicians rolling up their sleeves to show the vaccine was safe.

AstraZeneca said it would continue to analyze the U.S. data before submitting it to the FDA in the coming weeks. It said the data would also soon be published in a peer-reviewed journal.

The AstraZeneca shot is what scientists call a “viral vector” vaccine. The shots are made with a harmless virus, a cold virus that normally infects chimpanzees. It acts like a Trojan horse to carry the coronavirus’s spike protein’s genetic material into the body that in turn produces some harmless protein. That primes the immune system to fight if the real virus comes along.

Two other companies, Johnson & Johnson and China’s CanSino Biologics, make COVID-19 vaccines using the same technology but using different cold viruses.


LONDON (AP) — By MARIA CHENG and LAURAN NEERGAARD

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Pfizer vaccine efficacy falls to 84% after 6 months

Hala Turk

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Pfizer and BioNTech published on Wednesday new data indicating their COVID-19 vaccine efficacy decline from 96 percent to 84 percent over six months.

These numbers are regarded as a big motivator to the drug makers currently developing a third “booster shot” to target the Indian Delta variant. 

The released data shows that the antibody levels are much higher against the Alpha coronavirus variant and the South African Beta variant, after a third dose.

Based on the figures, the efficacy “declined gradually” as it dropped from 96 percent during the first week to around two months after receiving a second jab. The dose’s effectiveness then plummeted to 83.7 percent four to six months later with an average drop of 6 percent over the last two months.

The findings may be considered by U.S. health authorities in deciding when the pair’s booster shot might be needed.

The data, which involved tests of 23 people, was published by Pfizer and has not been peer reviewed by the scientific community.

The announcement of the data and was released on the day of the company’s earnings call.

During the call, Mikael Dolsten chief scientific officers described the new data on a third dose of vaccine “encouraging.”

“Receiving a third dose more than six months after vaccination, when protection may be beginning to wane, was estimated to potentially boost the neutralizing antibody titers in participants in this study to up to 100 times higher post-dose three compared to pre-dose three,” Dolsten said in a statement.

Despite Pfizer and its German partner BioNTech’s booster shot plans, both Centers for Disease Control and Prevention (CDC) as well as Food and Drug Administration (FDA) released a joint statement highlighting that Americans who have been fully vaccinated do not need a booster shot at this moment in time.

The statement noted that FDA, CDC, and National Institutes of Health (NIH) are engaged in a science-based process to consider whether or when a booster might be necessary.

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Google delays return to office, mandates vaccines

Associated Press

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Google delays return to office, mandates vaccines

Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.

The more highly contagious delta variant of the coronavirus is driving a dramatic spike in COVID-19 cases and hospitalizations. Google’s Wednesday announcement was shortly followed by Facebook, which also said it will make vaccines mandatory for U.S. employees who work in offices. Exceptions will be made for medical and other reasons.

In an email sent to Google’s more than 130,000 employees worldwide, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18 instead of its previous target date of Sept. 1.

The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.

“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.

And Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated. The requirement will be first imposed at Google’s Mountain View, California, headquarters and other U.S. offices, before being extended to the more than 40 other countries where Google operates.

“This is the stuff that needs to be done, because otherwise we are endangering workers and their families,” said Dr. Leana Wen, a public health professor at George Washington University and a former health commissioner for the city of Baltimore. “It is not fair to parents to be expected to come back to work and sit shoulder-to-shoulder with unvaccinated people who could be carrying a potentially deadly virus.”

Because children under the age of 12 aren’t currently eligible to be vaccinated, parents can bring the virus home to them from the office if they are around unvaccinated colleagues, Wen said.

Various government agencies already have announced demands for all their employees to be vaccinated, but the corporate world so far has been taking a more measured approach, even though most lawyers believe the mandates are legal.

Delta and United airlines are requiring new employees to show proof of vaccination. Goldman Sachs and Morgan Stanley are requiring their employees to disclose their vaccination status, but are not requiring staffers to be vaccinated.

Less than 10% of employers have said they intend to require all employees to be vaccinated, based on periodic surveys by the research firm Gartner.

While other major technology companies may follow suit now that Google and Facebook have taken stands on vaccines, employers in other industries still may be reluctant, predicted Brian Kropp, chief of research for Gartner’s human resources practice.

“Google is seen as being such a different kind of company that I think it’s going to take one or two more big employers to do something similar in terms of becoming a game changer,” Kropp said.

Google’s vaccine mandate will be adjusted to adhere to the laws and regulations of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.

“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.

Google’s decision to require employees working in the office to be vaccinated comes on the heels of similar moves affecting hundreds of thousands government workers in California and New York as part of stepped-up measures to fight the delta variant. President Joe Biden also is considering mandating all federal government workers be vaccinated.

The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.

The vaccine requirement rolling out in California next month covers more than 240,000 government employees. The city and county of San Francisco is also requiring its roughly 35,000 workers to be vaccinated or risk disciplinary action after the Food and Drug Administration approves one of the vaccines now being distributed under an emergency order.

It’s unclear how many of Google’s workers still haven’t been vaccinated. In his email, Pichai described the vaccination rate at the company as high.

Google’s decision to extend its remote-work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.

The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work triggered by the spread of the novel coronavirus.

Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home. This marks the third time Google has pushed back the date for fully reopening its offices.

Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks and minimize the need to wear masks in the office.

While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.


SAN RAMON, Calif. (AP)

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Vaccine maker BioNTech to use mRNA tech to target malaria

Associated Press

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Vaccine maker BioNTech to use mRNA tech to target malaria

Pharmaceutical company BioNTech said Monday that it wants to use the mRNA technology behind its coronavirus vaccine to target malaria.

The Germany-based company, which developed the first widely approved coronavirus shot together with U.S. partner Pfizer, aims to begin clinical trials for a “safe and highly effective malaria vaccine” by the end of next year.

“We are already working on HIV and and tuberculosis, and malaria is the third big indication (disease) with a high unmet medical need,” BioNTech’s chief executive, Ugur Sahin, told The Associated Press. “It has an incredible high number of people being infected every year, a high number of patients dying, a particularly severe disease and high mortality in small children.”

According to the World Health Organization, there were about 229 million cases of malaria worldwide in 2019. The global body estimates that 409,000 people died from malaria that year, with children under the age of 5 accounting for 67% of deaths.

Africa has by far the highest burden of the mosquito-borne disease worldwide, WHO says.

Sahin acknowledged that the effort is at a very early stage and there’s no guarantee of success. But he said the company believes it’s “the perfect time to address this challenge” because of the insights it has gained from developing an mRNA vaccine against the coronavirus and a growing understanding of how malaria works.

Experts say developing a vaccine to prime the immune system against malaria will be tricky, however.

“The genome of Plasmodium, the parasite that causes malaria, is more complex than viruses,” said Prakash Srinivasan, an assistant professor at Johns Hopkins Bloomberg School of Public Health.

A malaria vaccine made by drugmaker GlaxoSmithKline already being trialed in three African countries has shown that inducing strong, long-lasting antibody levels is challenging, he said.

Existing and future variants of the parasite could also pose a challenge to developing an effective vaccine, said Srinivasan, whose lab is also working to develop a shot against malaria.

But Barton Haynes, director of the Duke Human Vaccine Institute, said the experience of the COVID-19 pandemic showed mRNA technology could be used to quickly adapt vaccines to work against new variants.

“The mRNA platform is going to be applicable to many different pathogens,” he said.

Sahin said early-stage development and testing of vaccines normally costs about $30-80 million.

The project, which is a collaboration with the World Health Organization, the European Commission and the Bill and Melinda Gates Foundation, “has no budget limits at the moment,” he added.

BioNTech said it is also seeking to establish an mRNA vaccine production facility in Africa, which is among the regions that have struggled to get sufficient supply of COVID-19 vaccine doses.

The company said it is working with partners to “evaluate how to establish sustainable mRNA manufacturing capabilities on the African continent to supply African countries with vaccines.” Once built, such a facility would be able to make various mRNA-based vaccines.

BioNTech and Pfizer have said they will deliver 1 billion doses of their COVID-19 vaccine to middle- and low-income countries this year, and another billion doses in 2022.

Last week, the two companies announced that a South African firm, the Biovac Institute, will become the first on the continent to start producing their coronavirus vaccine.

BioNTech has previously said it is working on a vaccine candidate for tuberculosis, with clinical trials aimed for 2022, and therapies for several forms of cancer.


BERLIN (AP)

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