On Tuesday, the US Food and Drug Administrationof Pfizer-BioNTech and Moderna vaccines for Americans age 50 and older.
“Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns,” the agency said in a release.
The announcement comes just weeks after bothand petitioned the FDA to authorize an additional booster of their mRNA vaccines. Pfizer’s request was for adults 65 and older, while Moderna sought approval for all adults.
The FDA has also granted authorization for another booster for younger immunocompromised individuals who met certain criteria.
The agency made its decisions without convening its vaccine advisory committee, CNBC reported, something it’s been doing increasingly to expand the use of approved vaccines.
Read to learn the latest on the fourth vaccine shot, including who can get it and if it’s necessary for everyone.
Who is eligible for a fourth COVID shot right now?
As of Tuesday, anyone 50 or older is eligible for a second booster shot of either Pfizer-BioNTech’s Comirnaty or Moderna’s Spikevax vaccine.
In addition, individuals 18 and older who are immunocompromised or have other specific health issues — including people undergoing chemotherapy, organ and stem-cell transplant recipients, and those with HIV — have been approved for a second booster of Moderna’s vaccine. Individuals 12 and older who meet the same criteria can get another dose of Pfizer’s vaccine.
In both cases, the vaccine can be administered at least four months after a first booster dose is administered.
When will the US approve another booster for everyone?
Numerous studies indicate the effectiveness of COVID-19 vaccines decreases over time, and health officials continue to move toward recommending a second booster shot for the general population.
“The potential future requirement for an additional boost — a fourth shot for mRNA, or a third shot for Johnson & Johnson — is being very carefully monitored in real-time,” White House Chief Medical Adviser Dr. Anthony Fauci said in a February press briefing.
Israel, Germany, the UK, Sweden and Chile have already approved a fourth shot for older people or individuals with underlying health issues.
The FDA is potentially preparing to authorize another dose of mRNA vaccine for the general population in the fall, according to The Wall Street Journal.
Do you really need the fourth shot?
Hospitalizations and deaths from COVID-19 appear to be waning: While there were more than 12 million new cases last week, according to the World Health Organization, there was a 23% decline in mortality.
Still, that’s 33,000 deaths in one week.
“It is necessary for a fourth booster,” Pfizer CEO Albert Bourla told CBS’ Face the Nation earlier this month. The current three-shot protocol is “actually quite good against hospitalizations and deaths,” he added, “but it doesn’t last very long.”
A new, large-scale study from Israel demonstrates strong protection against severe COVID illness from a fourth vaccine dose, per the Jerusalem Post. The study included half a million people and found that a second booster reduced death from COVID by 78% in adults aged 60-100.
The FDA cited the study in its decision to approve another booster for seniors.
In a conversation hosted by CVS Heath Corporation last April, Bourla said one dose is enough for some vaccines, like for polio. But others, like the flu shot, have to be updated seasonally.
“The COVID-19 virus looks more like the influenza virus than the poliovirus,” he added.
But Moderna said it requested approval for all adults 18 and up really “to provide flexibility” to the CDC and health care providers in deciding who needs another booster.
The company’s president, Stephen Hoge, told Business Insider last week he thought a fourth dose was probably necessary only for seniors and immunocompromised people. Others could make their own choice.
“Is it necessary? I think that’s a strong word,” Hoge said. “I think it will provide a benefit to anyone who gets it.”
How long do COVID-19 vaccines remain effective?
Messenger RNA vaccines, like the ones offered by Pfizer and Moderna, offer good protection against serious COVID-19 complications — especially after a booster — but their potency wanes over time.
In a February advisory, the CDC reported that protection against hospitalization from mRNA vaccines dropped noticeably after just four months, even with a booster: When the delta variant was predominant, protection against hospitalization was 96% within two months of a third mRNA shot, but sank to 76% within four months.
During the omicron wave, protection from hospitalization fell from 91% within two months of an mRNA booster to 78% after four months.
A February metastudy in The Lancet determined mRNA vaccines, like Pfizer’s and Moderna’s, decreased in their ability to fight off infection by from 20% to 30% six months after a third shot.
Their protection against “severe” disease and hospitalization remained high in the same time frame, however.
For symptomatic COVID-19 disease, vaccine effectiveness decreased by roughly 25% across the board at the six-month mark, and by 32% in people age 50 and older.
A CDC study found vaccines’ protection against hospitalization when omicron was dominant dropped from a high of 91% within two months of a booster to 78% after four months.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
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