Scientists continue to say there isn’t enough evidence to make COVID-19 boosters available to all Americans

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The U.S. is only days away from President Joe Biden’s target date to begin rolling out COVID-19 booster vaccinations to Americans, although experts still say there is no scientific evidence to support the entire eligible population to stock up.

The Biden government announced last month that adults were vaccinated with the vaccines developed by BioNTech SE BNTX, + 4.90% / Pfizer Inc. PFE, -0.67% and Moderna Inc. MRNA, + 1.42% will qualify for a third dose starting Sept. 20. It’s been eight months since they received their first round of shots and US regulators gave it an “OK”.

However, the plan has been criticized by medical experts who say there isn’t enough clinical data to show that all Americans vaccinated with the mRNA syringes need a boost as they are now at greater risk of serious illness if they do become sick.

“Is that necessary now? Does the data justify a mass rollout to 150 million? [or] 200 million Americans younger and in good health? ”Asked John Moore, Professor of Microbiology and Immunology at Weill Cornell Medical College. “What we have to get away from is the idea that the vaccines fail because they just don’t.”

Everyone agrees that giving an extra dose of the vaccine to people with compromised immune systems is a science-based idea; However, the logic for widespread delivery of COVID-19 booster vaccines is unclear at best, and scientists and medical experts continue to oppose the lack of evidence.

“Is that necessary now? Does the data justify a mass rollout to 150 million? [or] 200 Million Americans Who Are Younger And In Good Health? We have to get rid of this notion that the vaccines fail because they just aren’t. “

– John Moore, Professor of Microbiology and Immunology, Weill Cornell Medical College.

A group of scientists, including two senior FDA officials who are reported to be retiring later this year, wrote in an opinion piece published Monday in influential medical journal The Lancet that the “evidence currently available does not require any show widespread use of booster vaccinations ”. among people who have already been vaccinated.

This assessment was released a few days before a group of independent advisors scheduled to meet on Friday to discuss whether the FDA should approve the booster vaccinations for BioNTech and Pfizer. The FDA released its own view on the companies’ request for a booster dose on Wednesday, saying that all COVID-19 vaccines in the US continue to provide strong protection against serious diseases.

Pfizer’s document, also released on Wednesday, argues that anyone who is at least 16 years old and has received their vaccine should get a booster shot. The drugmaker’s position is that although the vaccine continues to protect against hospitalization and serious illness in the US, based on what Pfizer is saying now happening in Israel.

Policy makers should consider boosters as a way to “control the increased transmission of B.1.617.2 (Delta) as we enter the upcoming fall / winter viral breathing season,” Pfizer said.

(Moderna has also filed an application for approval of a third dose of its COVID-19 vaccine because its vaccine is not yet fully approved by the FDA. Johnson & Johnson JNJ, -0.12% has not applied for a booster approval at the time. )

This is why the debate about COVID-19 boosters is so complicated

The public health goal during the pandemic has always been to prevent serious illness and currently most serious cases, including those leading to hospitalization and death, occur in the unvaccinated.

Even if the number of breakthrough cases among vaccinated people is increasing, this does not change the goal of preventing infection.

“At this point, I am not convinced that there is a need to empower the general population,” said Dr. Carlos del Rio, an infectious disease doctor and dean of Emory University School of Medicine, in an email. “There is some evidence from Israel that it could be important to this [older than] 60 years old, but for the general population I don’t think that’s the case. “

In addition, we don’t know whether the increase in COVID-19 cases among those vaccinated has more to do with declining immunity or the spread of the more highly transmissible delta variant. (Pfizer attributes the groundbreaking cases to declining immunity.) It’s also unclear what role the relaxation of mitigation measures like wearing masks and social distancing played on the summer wave, which is a topic in the Lancet article.

“Even without changes in vaccine efficacy, increasing success in delivering vaccines to large populations will inevitably lead to an increasing number of breakthrough cases, especially if vaccination changes behavior in those vaccinated,” the scientists wrote.

Here’s what we know COVID-19 boosters will do

The data provided by drug manufacturers indicate that booster vaccinations increase neutralizing antibody titers. This is an important metric when assessing the level of protection, but not the only one. Scientists also evaluate the T cell response.

Aside from immunocompromised people, experts say boosters are more likely to provide extra protection for people at high risk of serious illness, including the elderly and those with serious health problems.

SVB Leerink analyst Geoffrey Porges told investors on Thursday that he expects the US to introduce boosters in the next few weeks, but initially only for people 65 and over.

“Recent arguments from the departing FDA staff mostly point to issues of international justice and access to vaccines and the lack of clinical evidence to justify the need for a top-up,” he wrote. “While these are thought-provoking arguments in principle, the White House, FDA, and CDC commitments are first and foremost to protecting the lives of Americans.”

The US has been criticized for planning to offer Americans an additional 100 million doses if much of the world has not been vaccinated. But beyond the ethics of a booster program, getting limited additional vaccinations can be frustrating for Americans, especially those who worry who now assume they will be able to get a booster shot.

“You have now created an expectation in the public, at least in the public interested in vaccines. They are now expecting to get their boosters, ”said Moore of Weill Cornell. “As soon as you have offered the audience cake, you can no longer take the cake away from them and say we will not give you any more cake.”

This is what you should expect this week

  • The FDA’s Advisory Committee on Vaccines will meet on Friday to vote on whether regulators should approve BioNTech and Pfizer’s COVID-19 booster. This is a public session that will be webcast. The FDA is not required to follow the committee’s recommendations, but it often does. Moore predicts an “interesting” discussion at the meeting and says he doesn’t think there will be a solid agreement among committee members. “I don’t know which way the majority will go,” he said. “But it won’t be a unanimous decision.”

  • The CDC’s Advisory Committee on Immunization Practices traditionally meets next to make a recommendation on the administration of a vaccine in the United States. This vote will then be signed by CDC director Rochelle Walensky. (This is the same procedure followed for the emergency approval of any COVID-19 vaccine in the U.S.) An ACIP meeting on the matter is not yet scheduled.

Read more MarketWatch stories about COVID-19 booster shots:

Covid-19 vaccine booster shots are more complicated than it seems. Here’s why.

Doctors are questioning the optics and scientific rationale of the plan for COVID-19 booster vaccinations in the United States

Pfizer advocates COVID-19 booster vaccinations, but Fauci says we don’t need a third dose yet

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