Pfizer and BioNTech have asked the Food and Drug Administration to give the green light to a fourth dose of their COVID-19 vaccine for Americans 65 and older, companies announced on Tuesday, citing data of Israel suggesting that further reinforcement could curb infections and serious illnesses to the fullest. – Risk age group.
“Right now, as we’ve seen, a fourth reinforcement is needed right now,” Pfizer CEO Albert Bourla told Face the Nation. in an interview which aired on Sunday.
In a statement Tuesday, Pfizer and BioNTech noted a series of recently published studies as early evidence suggesting that “efficacy against symptomatic COVID-19 and severe disease caused by Omicron decreases between 3 and 6 months after receive initial reinforcement “.
“The protection you get from the third is good enough, actually pretty good for hospitalizations and deaths. It’s not that good against infections,” Bourla had said.
However, companies say they have not formally submitted these studies for the FDA to consider. Instead, Pfizer and BioNTech said their request was based on “two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating.”
Companies say additional reinforcement for seniors should improve protection if given at least four months after the first reinforcement.
In an analysis of Israeli Ministry of Health records, Pfizer and BioNTech say that serious disease rates for COVID-19 “were 4 times lower” among people who received their second boost in that timeline.
Israel was one of the first countries to distribute fourth doses to vulnerable populations during the winteras the cases of Omicron variants began to increase around the world.
The companies also say they studied antibodies extracted from 154 participants in a clinical trial in Israel who also received the extra dose in the same time period. Compared to antibodies extracted from people months after their initial boost, Pfizer and BioNTech say they saw a “10-fold increase in neutralizing antibodies” two weeks after the extra boost.
If authorized by the FDA and recommended by the Centers for Disease Control and Prevention, the measure could speed up a round of booster shots, federal health officials had said they hoped it wouldn’t be necessary until the fall season. , when many Americans receive their routine flu shots.
“The hope is that after our third injections we will be able to take advantage of it long enough for us to basically end up with an annual COVID-19 boost,” said Dr. Peter Marks, the FDA’s chief vaccine manager. organized event. by the University of California at San Francisco and Stanford University in January.
Moderna executives had echoed that timeline, and told investors last month that they were struggling to gather data on new COVID-19 vaccines for regulators to give the green light before a possible “fall reinforcement season.”
Federal officials have also suggested that only a few vulnerable groups could be recommended to receive the fourth dose.
Although data released by the CDC up to January suggest that COVID-19 hospitalization and death rates were lower among older people with a booster, compared with unvaccinated people or only their primary caregivers, rates among all groups rose during the Omicron wave to their highest levels in months.
“It is very likely that you will consider which subset of people have diminished, or not, protection against important parameters such as hospitalization,” Dr. Anthony Fauci, the president’s chief medical adviser, told reporters last month.
It is unclear whether the administration of Biden will be able to afford sufficient fourth doses. With a stalled funding application on Capitol Hill, the White House warned Tuesday that it would run out of money to buy future supplies of reinforcements.
At least 16.5 million Americans 65 and older have received a booster shot four months ago and may be eligible for the additional increase, according to CDC data.
“On the fourth injection, we now have enough for immunocompromised people who need a fourth injection. What we don’t have funding for is that if all Americans were needed to get an extra dose, we would need additional funding from Congress,” he said. to journalists a senior administration official.
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