A move announced by the Food and Drug Administration on Wednesday will make boosters available to the majority of adults who are fully vaccinated and have passed the recommended waiting period.
Currently, all Covid-19 vaccines approved in the United States also have boosters. And those who took shots of one company to get vaccinated could choose to get booster doses made by another company.
“Available data suggest weakened immunity in some fully vaccinated populations,” said FDA Deputy Commissioner Janet Woodcock. “The availability of these licensed boosters is important for continued protection against Covid-19 disease.”
Who gets the booster and when it depends on the original vaccine that person took.
Adults vaccinated with the J & J vaccine can receive boosters from Pfizer. Ltd
Partner BioNTech SE, Moderna, or J & J at least 2 months after a single dose.
The first person to receive the Pfizer-BioNTech or Moderna vaccine may be boosted at least 6 months after the second dose, as long as they are elderly or at high risk due to underlying illness or work. increase.
The FDA has already begun to consider whether to extend booster approval to more people. According to those familiar with the issue, this extension will make additional doses available to anyone over the age of 40 who has been vaccinated with the Pfizer-BioNTech or Moderna vaccine. The decision could be made in a few weeks, after which further approval for a younger age would follow, he said.
According to health officials, permission to use a combination of vaccines and booster immunizers ensures that anyone who wants the vaccine can get the vaccine, while at the same time increasing the options for fully vaccinated people. It will help.
Some studies have shown that mixed and matching people may get more protection, especially if they were first vaccinated with the J & J vaccine. Health officials say this option may also relieve people who are worried that side effects may occur if they are given the same vaccine again.
Shots may be available within a few days once the Centers for Disease Control and Prevention provides doctors, pharmacies, and vaccination sites with guidance on how to use them and who should get them.
The FDA, which regulates various medical products, must approve or approve the vaccine before it can be used outside of clinical trials. Once the vaccine is approved, the CDC sets policies on whether people should be vaccinated, in which groups and on what schedule.
The CDC will make a decision after a panel of experts will review the issue and make recommendations. The CDC Advisory Board will meet on Thursday.
According to people familiar with the matter, the United States needs to have enough vaccines to meet booster demand. People could get them in clinics, pharmacies and other vaccination sites.
The new authorization comes in the debate among health professionals as to whether many people really need to get a booster, or at least in the near future, whether the two shots will provide adequate protection. ..
According to the CDC, more than 69 million people in the United States have been vaccinated twice with Moderna.
Moderna’s original vaccine therapy, approved for adults in the United States in December 2020, requires two doses every 28 days. The Moderna booster dose will be half the dose for each of the first two shots.
Approximately 15 million people in the United States have been vaccinated with the J & J vaccine since it was approved as a single shot in late February.
The dose of J & J Booster Shot is the same as the first dose.
The Biden administration has sought boosters, especially to strengthen the immune defenses of people vaccinated against the infectious delta variant of the coronavirus. After clearing the original vaccine regimen last winter, the FDA is evaluating applications for adding additional doses.
In September, the FDA approved a booster dose of the Pfizer-BioNTech vaccine for seniors and adults at high risk for Covid-19 who have already been injected and have been vaccinated for at least 6 months. Did.
The FDA also approves boost immunization of Pfizer-BioNTech and Moderna vaccines for certain people with weakened immunity.
Boosters are also available in Israel, the United Kingdom and other countries.
Vaccine experts advising the FDA voted last week to recommend a third dose of Moderna shots to older people and others at risk of severe Covid-19. The panel also voted to recommend a second dose of J & J vaccine to all adults who received the first dose.
One problem observed in a small number of people who received the Modana double-dose regimen, especially in young adult men, is inflammatory heart disease called myocarditis and peritonitis. In some European countries, the use of Moderna vaccines in the younger age group is restricted due to potential risks.
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The FDA noted the risk of myocarditis in the approval of the Moderna booster shot, but did not specifically state whether the risk after booster administration and after primary vaccination was the same.
A study assessing booster doses is too small to adequately assess the risk of myocarditis, Doran Fink, deputy director of the FDA’s vaccine division, said in an advisory board last week. Pfizer’s Covid-19 vaccine is also associated with an increased risk of myocarditis.
So far, according to the CDC, 11.2 million people in the United States, or about 5.9% of the fully vaccinated population, have been boosted.
Mixing and matching decisions were communicated by a National Institutes of Health study showing that vaccination with a different vaccine than the original vaccine increased antibody levels in all three vaccine types, especially among J & J recipients. increase.
NIH studies show that booster-immunized J & J vaccine recipients at Moderna doses increased antibody levels 76-fold, Pfizer boosters increased antibody levels 35-fold, and J & J doses increased antibody levels 4-fold. it was done.
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Moderna and J & J Covid-19 boosters, mixing and matching are FDA approved
Source link Moderna and J & J Covid-19 boosters, mixing and matching are FDA approved