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Not prudent to deploy vaccine boosters at this level: Ex-FDA director

There is currently insufficient evidence that Covid vaccine booster shots are required, according to a former FDA director.

“It is a good thing to be prepared to make boosters, but we really don’t have … evidence, at least in the United States, where we’re seeing vaccine failures or a decrease in immunity, so it’s time to put a booster on “said Norman Baylor, who previously worked for the US Food and Drug Administration’s Vaccine Research and Review Bureau.

Pharmaceutical company Pfizer is developing a Covid booster, or third dose, to combat the highly transmissible Delta variant, which has become the dominant strain in many countries, including the United States

The Centers for Disease Control and Prevention and the FDA said in a joint statement last week that “Americans who have been fully vaccinated currently do not need a booster dose”.

Pfizer met with U.S. officials Monday to plead for a third shot.

The company worked with German company BioNTech to develop a vaccine consisting of two doses given three weeks apart. In December it received emergency approval from the World Health Organization.

No significant vaccination failure

The vaccine errors are currently very small with the vaccines currently in use. Until that changes, I don’t think it would be advisable to give a booster dose.

Norman Baylor

CEO of Biologics Consulting

Westbury, NY: A man receives the Moderna COVID-19 vaccine while at the Long Island State Qualified Health Center in Westbury, New York on April 29, 2021. (Photo by Steve Pfost / Newsday via Getty Images)

Steve Pfost | News day | Getty Images

He said health officials seem to agree that a third dose is not required.

“We’re just not there yet … we have no evidence that it is time to get a booster,” he said, adding that there may be new variations in the future that make current vaccines ineffective or much less effective.

Vaccination inequality

Richer countries have been able to vaccinate a large part of their population, while poorer countries lag behind.

The issue of vaccine disparity between regions needs to be addressed, Baylor said.

“A pandemic itself, the definition is that it is global,” he said, adding that he agreed with the World Health Organization that the crisis must be viewed from a global perspective.

Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers and those most at risk.

Tedros Adhanom Ghebreyesus

Director General, World Health Organization

WHO director general Tedros Adhanom Ghebreyesus said Monday the world is “in the midst of a growing two-pronged pandemic”.

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers and the most vulnerable,” he said during a press conference, adding that the world Make “conscious choices” so as not to protect those most in need.

The data suggest the vaccines offer long-lasting immunity to severe and deadly Covid-19, he said.

“The priority now must be to vaccinate those who have received no doses and no protection,” said the WHO chief.

Biotech companies such as Pfizer-BioNTech and Moderna, which have developed another mRNA vaccine against Covid-19, must “give everything” to direct supply to the places in need, including through the Covax vaccine distribution alliance, he added.

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Health

White Home to deploy response groups throughout U.S. to fight Covid variant

The White House is deploying Covid-19 response teams across the United States focused on combatting the highly contagious delta variant, the Biden administration announced Thursday.

The teams, comprised of officials from the Centers for Disease Control and Prevention and other federal agencies, will work with communities at higher risk of experiencing outbreaks and will focus on increasing the rate of Covid-19 vaccinations, White House Covid czar Jeff Zients said during a White House news briefing on the pandemic.

The teams will also increase testing to expand detection of the virus, facilitate contact tracing and provide therapeutics to help treat those who become infected, he said, adding the government is ready to provide additional personnel.

There are 1,000 counties in the U.S. that have vaccination coverage of less than 30%, CDC Director Dr. Rochelle Walensky said at the briefing. These counties, primarily in the South and Midwest, are the most vulnerable to the variant, she said.

“To be clear, the federal government stands ready to meet the moment and work with our state partners to respond to the delta variant,” Zients said.

“As we continue to work with communities across the country to get more shots in arms, we will also be working with governors and state and local health authorities to identify and address the needs on the ground in places with emergency outbreaks,” he added.

The Biden administration’s comments come just ahead of the Fourth of July weekend, when many Americans are expected to gather for fireworks, barbeques and other large, in-person activities.

Delta, first identified in India but now in at least 96 countries, is expected to become the dominant variant of the disease in the U.S. The prevalence of the delta, estimated to be about 60% more transmissible than the alpha variant first found in the U.K., is doubling in the U.S. about every two weeks, according to the CDC.

Health officials say there were reports that the delta variant also causes more severe symptoms, but that more research is needed to confirm those conclusions. Still, there are signs the delta strain could provoke different symptoms than other variants.

This is a “highly contagious virus,” said Dr. Paul Offit, a pediatrician and vaccine advocate who has served on advisory panels for both the CDC and the Food and Drug Administration.

“We need to vaccinate now. I mean get everyone vaccinated now because these mutations are going to continue to occur,” he said. It’s only July but “as we head into the fall and early winter you’re going to see a surge and there are too many people in this country who are still unvaccinated.”

Delta accounts for around 26% of Covid cases in the U.S., the CDC has estimated. Dr. Anthony Fauci, the White House’s chief medical advisor, has called the variant the “greatest threat” to the nation’s attempt to eliminate Covid-19.

The WHO has said the variant is the fastest and fittest coronavirus strain yet, and it will “pick off” the most vulnerable people, especially in places with low Covid vaccination rates. It recently urged everyone, including vaccinated people, to continue to wear masks as the variant spreads.

In some regions of the country, nearly one in two sequences is the delta variant, Walensky said Thursday. As the variant spreads, officials expect to see an increase in transmission unless states can vaccinate more people, she added.

As of Thursday, more than 181 million Americans, or 54.6% of the U.S. population, have had at least one dose of a Covid vaccine, according to data compiled by the CDC. More than 155 million Americans are fully vaccinated, according to the CDC.

“The delta variant is predicted to be the second most prevalent variant in the United States, and I expect that in the coming weeks it will eclipse the alpha variant,” she said, urging those with symptoms to get tested for Covid.