The Food and Drug Administration (FDA) has authorized second booster shots, and fourth shots overall, of the Pfizer-BioNTech and Moderna COVID-19 vaccines for Americans 50 and older, the companies announced Tuesday morning.
Immunocompromised adults over the age of 12 can also now receive an additional Pfizer dose, and those 18 and older are eligible for Moderna’s fourth shot. The second booster is to be distributed four months after the first.
Americans 12 and older with particularly weak immune systems because of a serious condition are now eligible for a fifth shot, four months after the previous, the agency also decided.
Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults ‘to provide flexibility’ for the government to decide who really needs one.
The FDA approval comes as uptake for the additional shots in the U.S. wanes and both Covid cases and deaths reach the lowest points since well before the Omicron-fueled winter virus surge.
Fourth doses of both the Pfizer and Moderna COVID-19 vaccine shots were approved by the FDA on Tuesday for Americans 50 and older, and those who are immunocompromised as young as 12 for the Pfizer jab, and 18 for the Moderna jab (file photo)
Pfizer is expected to raise over $30 billion in revenue from its COVID-19 vaccine this year, and CEO Albert Bourla (left) has said these shots will be needed for potentially the next ten years. Moderna CEO Stephane Bancel (right) said that the fourth shots will be needed to prevent an upcoming surge of the ‘stealth’ variant, though others have disagreed that another large Covid wave is around the corner
Moderna and Pfizer have often submitted an abundance of data to regulators to ‘provide flexibility’ and also to get an early jump of issues that may arise in the approval process.
What Moderna did for this shot, and what both companies did for the first booster dose, is submit a flexible application that can be approved over time.
While those 50 and older were approved Tuesday, it is likely that will be expanded to 18 and over once regulators feel that protection provided by the initial booster dose has waned.
Both companies went through this process for the first booster dose as well, with it first approved for Americans 65 and older, and then the age was slowly lowered until it reached 18 and older at the start of the Omicron surge.
Americans under the age of 50 can still receive the shot off label at certain health clinics because it has now received FDA authorization, though they would need to convince a doctor or vaccine provider to distribute it to them.
There’s limited evidence to tell how much benefit another booster could offer right now.
FDA made the decision without input from its independent panel of experts that has wrestled with how much data is required to expand shots and not all experts believe the shot is necessary.
Dr Anna Durbin is an international public health expert at Johns Hopkins University in Baltimore, Maryland, and has been a critic of Pfizer, Moderna and the White House’s insistence to roll out COVID-19 booster shots before they are needed.
Last week, she told ABC that she does not believe many Americans will benefit from additional shots.
For now, both shots are only available on-label to Americans over the age of 50, but that authorization will likely be extended when regulators see fit. Moderna has already applied for all adults 18 and over to get the fourth jab. Pictured: A man in Hines, Illinois, receives a shot of a COVID-19 vaccine
The FDA chose not to use an outside panel of experts in the approval process for these shots, and some experts disagree that the fourth jabs are needed at this point (file photo)
‘There are very few, if any, people who, in my opinion require a fourth dose,’ she said.
In August, when the White House was laying out plans to roll out the first batch COVID-19 booster shots, Durbin was also a critic, telling DailyMail.com that there was little science backing up the decision.
‘In general, it’s too early to recommend a fourth dose, except for those who are immune compromised,’ Dr Paul Goepfert, professor of medicine at the University of Alabama at Birmingham, told ABC.
The next shot is being rolled out earlier than expected out of fear of the BA.s ‘stealth’ variant, a lineage of Omicron.
The ‘stealth’ variant, which earned the moniker from its ability to avoid detection through some sequencing methods, is believed to be the most infectious version of Covid yet – but is just as mild as the BA.1 version of Omicron that took over the world last last year.
It is now the dominant strain in the U.S., the Centers for Disease for Prevention (CDC) reported on Tuesday, making up 55 percent of active cases in the country.
Moderna CEO Stephane Bancel said last week that he expects the U.S. to suffer a BA.2-fueled surge sometime soon, though, and that his company’s vaccine will be needed to control it.
‘Already several countries around the world have some of the 4th dose testing in people at high risk,’ Bancel told CNBC’s Squawk Box.
‘There’s a big wave of BA.2 variant in Europe right now, as many public health experts have said this should start in the U.S. very soon.’
A growing list of experts are saying the exact opposite, though.
‘I would not be surprised at all, if we do see somewhat of an uptick,’ Dr Anthony Fauci, the nation’s top infectious disease expert and someone who has frequently been among the more cautious voices during the pandemic, said at a Washington Post event last week.
‘I don’t really see, unless something changes dramatically, that there would be a major surge.’
Fauci, Bancel and Pfizer CEO Albert Bourla have been among those saying an additional dose was on the way for months, with Bourla even saying annual jabs will be needed for the next decade to control the pandemic.
While the shots have been deemed safe and effective by health officials around the world, and have likely saved millions of lives over the past year, Pfizer and Moderna’s goals in the vaccine rollout are not exactly humanitarian.
The companies have each made billions off of the sales of vaccines to the U.S. and other nations around the world.
Pfizer, its partner BioNTech, and Moderna estimate a combined $50 billion in COVID-19 vaccine sales this year.
As the nation begins to purchase even more vaccine doses, these revenue targets may increase even more.
