On Tuesday, Pfizer and BioNTech requested the Food and Drug Administration (FDA) for an emergency use authorization for a second booster of the coronavirus vaccine for adults aged 65 and over.
The two companies said there is new evidence that the vaccine’s effectiveness against symptomatic and serious illnesses caused by the Omicron mutant diminishes 3-6 months after receiving the first booster. rice field.
As a result, the two companies stated that a second boost could be given at least 4 months after the first boost to return antibody levels to peak levels after the third.
Additional doses for older Americans will enhance its weakened immunity. Adults over the age of 65, even vaccinated, are most vulnerable to severe COVID-19 infection.
Booster shots are currently allowed for everyone over the age of 12 on an emergency use basis. The FDA has fully approved the first two doses of the Pfizer COVID-19 vaccine.
According to both companies, the submission is based on two actual datasets from Israel analyzed during the widespread distribution of Omicron variants. Israel is one of the only countries to approve a fourth dose of the vaccine.
A study, Post In February, it was sent to a preprint server to track infections in 1.1 million people over the age of 60, with a confirmed infection rate of 2 individuals who received a second boost at least 4 months after the first boost. It turned out to be one-third. The incidence of severe illness was one-quarter.
The two companies also included a second Israeli study testing additional booster doses of both Pfizer and Moderna vaccines in healthcare professionals over the age of 18.according to Preprint In the study, there was a marked increase in neutralizing antibodies, especially against Omicron.
Although the study did not reveal new safety concerns, boosters were ineffective in preventing symptomatic infections, and breakthrough infections were common. The Pfizer vaccine was 30% effective against infection and the Moderna vaccine was only 11%. People have also been observed to have high viral load, even with mild infections. This means that the virus can be easily spread to others.
The mixed results could rekindle the debate about the effectiveness of booster shots and the Biden administration’s booster strategy.
Many health professionals questioned the effectiveness of booster shots in young, healthy people before the Omicron variants began to spread and evidence showed a significant decline in immunity.
Part of the debate focused on whether it was to prevent people from being hospitalized with COVID-19, or to prevent them from getting sick, even if they were mild.
The news arrives a few days after Pfizer CEO Albert Bourla says he needs another booster shot.
“For now, as we have seen, we now need a fourth booster. The protection we get from the third is sufficient and is actually very suitable for hospitalization and death,” Bourla said. Is CBS’s “Let’s confront the nation.”
“It’s not very good for infectious diseases, but it doesn’t last that long, but we’re just submitting those data to the FDA. [Food and Drug Administration]And we’ll see what the experts say outside of Pfizer, “he added.
Pfizer’s request also said that cases of COVID-19 were declining in the United States and that the US Centers for Disease Control and Prevention no longer required indoor masking in most parts of the United States.
Updated at 7:04 pm
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