The Pfizer CEO says the company is reporting to the Food and Drug Administration that a fourth dose of its COVID-19 vaccine is needed. While the injection currently made by Pfizer with the help of BioNTech still protects against severe disease, the drug maker now believes another booster is needed to prevent infections.
“Right now, as we have seen, a fourth booster is needed now. The protection you get from the third is good enough, actually pretty good for hospitalizations and deaths. It’s not that good against infections,” Pfizer CEO Albert Burla said in an interview with Face the Nation that aired Sunday.
Stephen Danehee, a spokesman for Pfizer, said Burla was referring to “early and preliminary” data, and pointed to a study announced in January that looked at both the fourth dose of the currently approved formulation and one targeted for the Omicron variant.
“We will continue to collect and evaluate all available data and maintain an open dialogue with regulators and public health authorities to help develop a COVID-19 vaccination strategy as the virus evolves,” Danehy said in a statement.
A White House spokesman has submitted requests for representation to the FDA. A spokesperson for the agency did not respond to a request for comment.
Burla previously described the company’s presentation to CNBC as “a significant package of data about the need for a fourth dose.” His findings echoed trends seen by health authorities around the world who were looking into vaccine efficacy during the wave of Omicron options earlier this year.
A cohort study published by the Centers for Disease Control and Prevention last month found that the effectiveness of the COVID-19 vaccine in emergency rooms or emergency room visits dropped to 66% among those who received a third dose of one of the mRNA vaccines from four up to five months. back. The vaccine was 78% effective against COVID-19 hospitalizations among this group.
Burla said that in addition to the fourth shot, the company is trying to create a new vaccine “that will protect against all options, including Omicron, but also something that can protect for at least a year.”
“Omicron was the first to skillfully evade the immune protection we give. But we also know that the duration of protection is not very long,” he said.
Federal health officials have previously said that an additional booster shot will likely be needed to prevent new waves of the virus, though perhaps not until the fall for most people.
“We hope that after our third shots we can get enough time from them to eventually get our annual COVID-19 booster,” Dr. Peter Marks, a senior FDA vaccine official, said at the event. UC San Francisco and Stanford University in January.
The schedule was backed by executives from Moderna, which is also looking to trial new versions of its COVID-19 vaccine, hoping to get a green light from regulators ahead of a potential “fall booster season.”
“The time has come to update the vaccine against the mutations that are currently circulating and increase resistance to these new variants of concern. But it does run into the issue of these filings,” Moderna president Stephen Hoge told investors last month.
However, officials said the timing of the fourth dose could be accelerated for groups more vulnerable to major breakthrough infections as the virus continues to spread.
“I don’t think you’re going to hear, if so, any recommendations that would be universal for everyone,” Dr. Anthony Fauci, the president’s chief medical adviser, told reporters last month.
According to the CDC, about half of all vaccinated adults and more than two-thirds of vaccinated older Americans have received a booster shot.
Although the rate of new cases and hospitalizations across the country continues to decline after the surge in Omicron earlier this year, more than a thousand COVID-19 deaths per day are still being recorded on average.
In Europe, which also saw a sharp drop in infections following the Omicron surge, the rate of new cases is picking up again after several countries lifted their pandemic restrictions.
“It is very likely that it will take into account which subgroup of people have reduced or no protection from important parameters, such as hospitalization,” Fauci said.
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