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BionTechPfizer just made this important announcement about its vaccine! This is what you should know and pay attention to now!
The vaccine maker is planning the next step in its fight against COVID
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Across the U.S., people are receiving additional vaccinations to protect against the coronavirus. According to the Centers for Disease Control and Prevention (CDC), more than 25 million people have already received a booster shot. That agency, along with the U.S. Food and Drug Administration (FDA), expanded eligibility for the COVID booster vaccination to Moderna and Johnson & Johnson recipients in late October. However, many Pfizer patients have already been eligible since late September, so more than 16 million people have received this booster shot so far. Now the vaccine maker is planning the next step in its fight against COVID.
New statement issued!
Pfizer and BioNTech issued a statement on November 9 announcing that they have just submitted an application to the FDA to expand approval for their booster. The vaccine makers are asking the agency to approve Pfizer’s booster for everyone 18 and older.
In mid-October, Pfizer CEO Albert Bourla told MarketWatch that he had received a booster himself and that he expected federal regulators to make the booster widely available in the U.S. soon. “They will probably move the recommendations to an earlier age, as they have done in England and other countries,” he said. In Britain, booster shots are available to people over 50, and in Israel, booster shots have already been given to 12-year-olds.
Will everyone soon be entitled to a booster?
Currently, in the U.S., only individuals under the age of 65 are eligible to receive a booster vaccination from Pfizer if they are at high risk for severe COVID for medical, occupational or institutional reasons. The only exception is Johnson & Johnson recipients 18 years of age and older, all of whom are eligible for a booster shot and can choose Pfizer because the FDA and CDC allow mixing and matching of vaccines.
According to the New York Times, the FDA is expected to approve Pfizer’s request for expansion before Thanksgiving and in time for the Christmas travel season. This would likely make every adult in the U.S. eligible for an additional dose. This aligns with the views of several experts, who argue that there is now “stronger data” supporting the need for booster shots than there was in September, when the FDA made its initial decision on Pfizer’s booster.
93% lower risk of severe course
“I think it appears that booster vaccines can now help prevent severe disease in many more people than we previously thought,” Dr. Nahid Bhadelia, director of the Boston University Center for Emerging Infectious Diseases Policy and Research, told The New York Times.
An Israeli study published Oct. 29 in the journal The Lancet analyzed nearly 730,000 people who had received a booster dose of Pfizer’s vaccine and found that those who had received a booster dose had a 93 percent lower risk of hospitalization, a 92 percent lower risk of severe illness and an 81 percent lower risk of death than those who had received only two shots of the vaccine.
Pfizer and BioNTech said their new filing was based on data from their own clinical trial – conducted in part in the U.S. – that showed similar results. According to the data released in late October, a study of more than 10,000 volunteers aged 16 and older showed that a booster shot restored vaccine protection against COVID with a 95.6 percent efficacy rate.
No booster for everyone yet
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“These important data provide further evidence that booster vaccination of our vaccine can help protect a broad population from this virus and its variants,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement at the time.
When regulators first voted to approve the Pfizer vaccine two months ago, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) specifically recommended that the booster vaccine not be expanded to all adults who originally received the Pfizer vaccine. Several members of the committee had expressed concern at the time that young, healthy people should also have access to booster vaccines – and some officials still hold that view.
Dr. Anna Durbin, an internal medicine physician who specializes in infectious diseases and a professor of international health at the Johns Hopkins Bloomberg School of Public Health, told CNBC that the benefit of booster vaccination for young, healthy people is “limited.” An additional vaccination does increase antibody levels, “but if you’re young and healthy, you don’t need it now,” Durbin said. “You want to save that for later.”
Still, Moderna is expected to submit its own application to the FDA to expand the booster’s approval terms, according to the New York Times. According to the New York Times, however, some experts predict that even an expanded approval of the Moderna booster could exclude one group of people: young men.
Younger men are at higher risk of a rare, serious side effect called myocarditis (heart inflammation) after treatment with the Moderna vaccine. The FDA even recently postponed extending the Moderna two-dose vaccination series to adolescents to test for this reaction, the Wall Street Journal reported.
“The younger the age groups get, the lower the personal risk of severe COVID and the higher the risk of cardiac inflammation with the mRNA vaccine,” said Ofer Levy, voting VRBPAC member, on CNBC’s Closing Bell.