The U.S. Food and Drug Administration on Thursday authorized a booster dose of the COVID-19 vaccines from Pfizer-BioNTech and Moderna for people with weakened immune systems.
Thursday’s revised emergency use authorization clears the way for people who have had an organ transplant, or those with a similar level of compromised immune systems, to get an extra dose of the same injection they initially received. Mixing of mRNA vaccines is allowed in the third shot if the original vaccine is not available.
An advisory committee to the US Centers for Disease Control and Prevention (CDC) voted on Friday to recommend additional doses, an important step before the policy is implemented.
Patients will not need a prescription or health care provider approval in order to prove they are immunocompromised and to receive the extra dose, according to CDC officials.
“It will be the patient’s testimony, and no proof, prescription or recommendation from the individual’s health care provider will be required,” said CDC official Dr. Amanda Cohen.
It only applies to bi-vaccine vaccines at the moment
The Centers for Disease Control and Prevention said the FDA’s decision does not apply to people who have received a single dose of the Johnson & Johnson vaccine, because there is not enough data to support additional doses yet.
“We believe this is at least a solution for the vast majority of immunocompromised individuals, and we think we will likely have a solution for the rest in the not too distant future,” FDA official Peter Marks told the CDC. face.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are working to ensure that immunocompromised recipients of the J&J vaccine are optimally protected, according to the CDC.
Coronavirus cases in the United States rose to their highest level in more than six months, driven by the delta variable, according to Reuters statistics.
The vulnerable group makes up less than 3 percent of adults in the United States, which translates to about 10 million Americans, CDC director Rochelle Wallinsky said before licensing.
A few other countries, such as Israel and Germany, are planning or have previously managed the third shot to avoid another crisis due to the contagious delta type of coronavirus.
In Canada, the National Immunization Advisory Committee (NACI) told CBC News in a statement that it “continues to closely monitor emerging evidence regarding the effectiveness of COVID-19 vaccines in those who are immunosuppressed, including evidence of the need or potential benefit of a third dose in This population group.
The statement also said that the NACI will update its recommendations in the coming weeks.
Questions of Injustice and Necessity
Scientists remain divided over the widespread use of boosters for the COVID-19 vaccine among those without underlying problems as the benefits of boosters remain undetermined.
Pfizer said the effectiveness of the vaccine it developed with BioNTech declines over time, citing a study that showed 84 percent efficacy from a peak of 96 percent four months after the second dose.
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Moderna also said it sees the eventual need for booster doses, especially since the delta variant has caused “breakthrough” infections in fully vaccinated people.
Reports of infections among vaccinated people and concerns about diminishing protection have prompted wealthy nations to dispense booster doses, even as many countries struggle to reach their first vaccine doses. Last week, the World Health Organization called for a moratorium on COVID-19 booster vaccinations.
Pfizer, along with its German partner BioNTech, and Moderna together raised more than $60 billion in shot sales in 2021 and 2022 alone. The agreements include the supply of the first two doses of vaccines, as well as potentially billions of dollars in boosters for rich countries.
Going forward, analysts expect revenue of more than $6.6 billion for Pfizer-BioNTech and $7.6 billion for Moderna in 2023, mostly from booster sales.