Pfizer and BioNTech to seek approval for second coronavirus booster for people 65 and older

In a separate move to address longer-term questions about recall strategies, the FDA plans to convene its outside advisers in early April to determine whether there should be an October or November campaign to encourage some or all adults to get additional boosters and whether the shots should be the same as the current vaccine or revamped to counter new variants, according to a federal official who spoke on condition of anonymity to discuss administration plans.

The official said: “Would it be a good idea to have some sort of recall campaign for all or part of the population in the fall to prevent a wave of infections” as the weather turns cold again?

Increasingly, some officials have signaled that they believe adults of all ages may need a second booster due to the lack of durability of two-shot mRNA vaccines made by Pfizer-BioNTech and Moderna.

Albert Bourla, CEO of Pfizer, has said in recent days that he believes a second booster will be needed for everyone. During a Washington Post Live event last week, Bourla said a fourth shot would be needed as immunity wanes.

“We are currently working very intensively. …I think our data suggests that they [a fourth dose] protect – they significantly improve protection, the fourth dose compared to the third for omicron after a while, after, say, three to six months,” Bourla said.

He told CBS’ “Face the Nation” in an interview that aired Sunday that a fourth dose would be “necessary.” He said the protection provided by the first booster is “actually quite good for hospitalizations and deaths. It’s not so good against infections. Pfizer and BioNTech are working on a vaccine that will work against all variants and provide protection for at least a year.

Pfizer spokeswoman Jerica Pitts declined to confirm the potential emergency authorization filing and said the company “continues to collect and evaluate all available data and we are in ongoing and open dialogue.” with regulators and health authorities to help inform a COVID-19 vaccination strategy as the virus evolves.

The FDA declined to comment.

In a recent interview, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said U.S. data so far shows severe disease protection remains robust four to five months after a recall. – falling somewhat from 91% effectiveness in preventing serious illnesses. 78 percent effective disease.

“The proof in the pudding is how long the protection lasts after a third push – five, six, seven, eight months,” Fauci said. “If it goes down, you decide whether you’re going to boost based on the clinical data.”

It’s unclear what Israeli data Pfizer will submit for its bid to find a second booster for people 65 and older, but officials within the Biden administration are seeking clarification on two fronts. They want to see how much immunity wanes after the first booster and how effective a second booster is. Some preliminary data on the effects of a fourth dose have been made available from Israel, where a fourth dose has been used in people 60 years and older, healthcare workers and immunocompromised people. Some of this data has been mixed.

A study, posted on a preprint server ahead of peer review, tracked infections and hospitalizations in Israel in the second half of January, after a fourth dose began being offered. In people 60 and older who received a fourth injection, infection rates were lower after the fourth dose. Rates of severe illness were significantly lower among people who received a fourth injection.

“Giving the fourth dose to people who were at risk of developing severe disease helped limit the burden on hospitals in Israel during the rapid and widespread rise of Omicron,” the researchers concluded.

But a separate pre-print study from Israel that tested a fourth vaccine in health workers showed a mixed picture. A fourth shot from PfizerBioNTech or Moderna increased anti-virus antibodies, but was not very effective in preventing mild or asymptomatic infections. This suggests that as a longer-term strategy – and for people who are not at high risk of severe disease – a fourth vaccine may not be the ideal way to boost immunity. Breakthrough infections were common and people had large amounts of virus in their noses, suggesting they could infect others.

Pfizer and BioNTech are also officially testing a fourth vaccine in a clinical trial that began in January. In a group of 600 fully vaccinated and boosted people, they compare a version of their vaccine refined to fight the omicron variant to a fourth shot of the regular vaccine.

The American public — and even experts — have been sharply divided on coronavirus vaccines and boosters, with the United States falling far short of vaccination rates seen in many other countries. Pfizer’s announcement that a third vaccine would be needed last summer helped sow some of that confusion. The venture was rebuffed by government officials, who had not yet been convinced that one was needed, although they called them later.

Now, with some studies showing that the vaccine’s effectiveness has diminished to some extent against the highly contagious omicron variant, some older people are clamoring for a second booster – or getting one before it’s even officially licensed. .

But other individuals, of all ages, seem to have little interest in the snaps, especially as the omicron threat fades and infections and hospitalizations plunge.

Officials in the Biden administration and the public health community are closely monitoring the rise in covid-19 cases in Europe and the proliferation of the omicron BA.2 variant. Some experts fear there will be an increase in cases in the United States following the relaxation of mask requirements as BA.2, which is more transmissible than the original omicron version, becomes dominant .

A study published last month in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report suggested that booster shots of the Pfizer-BioNTech and Moderna vaccines lost some effectiveness after four months, but still offered strong protection against serious illnesses and hospitalization. The study indicated that the vaccine appeared to be more effective against the earlier delta variant than the omicron variant.

In January, Israel began offering a fourth dose of the Pfizer-BioNTech vaccine to people 60 and older and medical workers. In France, second boosters are available for all people aged 80 and over, and people who are immunocompromised or have a long-term illness. Chile and Germany also recommend fourth injections for high-risk groups.

In the United States, four injections of the vaccine are already authorized for people with moderately or severely weakened immune systems, which hinder an effective response to the vaccine.

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