CNN
–
U.S. Food and Drug Administration Revised On Tuesday, its emergency use authorization for Pfizer and Hyundai’s bivalent vaccines granted additional doses for those aged 65 and older, as well as some people with weak immunity, before vaccination campaign this fall.
The bivalent vaccines issued by Pfizer and Moderna carry instructions to fight the original strain of Virus 19 and Omicron and its derivatives.
They are available in the United States Since September Under the emergency use authorization or EUA, how to give a vaccine is strictly limited.
On Tuesday, the FDA changed the authorization terms of these vaccines so that some people can have an additional dose in front of most others.
That is, adults aged 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months after the first dose.
Most people with some degree of immune depression receive the first dose of the divalent vaccine, which can be obtained at least 2 months later. Additional doses may be at the discretion of their healthcare provider.
Dr. Peter Hotelz, who co-chairs the Vaccine Development Center at Texas Children’s Hospital, has been calling on the FDA to increase the chances of bivalent boosters for those who want them. He said that in most cases, the agency’s guidance today makes sense.
“My only question is why the age cutoff for 65? What is that based on? Usually, I would rather lower it to 60 or even 50,” Hotelz said in an email to CNN.
“For those Americans who understand their importance, we should make a second bivalent booster available. Finally, we need guidance on another annual fall booster very soon. This is probably sometime this summer,” he added.
For immunocompromised children aged 6 months to 4 years of age, eligibility for additional bivalent doses will depend on the vaccine previously received, the FDA said in a press release.
Another big change, the agency said, is that most unvaccinated people may now receive a bivalent vaccine instead of the meat-changing dose of the original single vaccine. The FDA has simplified advice for unvaccinated people after recognizing that most Americans now have some immunizations to Covid-19, even if it is through past infections.
“There is now evidence that the antibodies against SARS-COV-2 by most U.S. populations aged 5 and older are the virus that causes COVID-19, whether vaccinated or infected, can serve as the basis for protection provided by bivalent vaccines. Covid-19 remains a real risk for many and we encourage individuals to consider staying up to date with vaccination, including bivalent Covid-19 vaccines. The available data continue to demonstrate that vaccines can prevent the most severe outcomes of Covid-19, which are serious diseases, hospitalizations and deaths.” Press release.
Children aged 6 months to 5 years old who have not been vaccinated may now receive two doses of the Modern Bivalent Vaccine as a two-dose vaccine in their main series, or if they are a three-dose series of Pfizer-Biontech aged 6 months to 4 years old. Children aged 5 may receive two modern bivalent doses or one dose of Pfizer-Biontech bivalent vaccine.
Children aged 6 months to 5 years old start receiving monovalent vaccines and are now able to receive bivalent vaccines, but the number of doses they are eligible for will depend on the number of doses they already have and what kind of vaccine they have received.
The agency stressed that most people taking a first-dual dose of the vaccine are not currently eligible for a second dose.
They encourage everyone who hasn’t received the first dose of the divalent vaccine yet to do so, and many Americans are still in that bucket.
In one in five Americans, only about 17% of eligible doses meet the recommended dose.
Over time, adults with reduced immune function have been asking their doctors if they need another bivalent vaccine due to age or potential health problems.
The Centers for Disease Control and Prevention reported early data that the effectiveness of the bivalent vaccine has begun to diminish even for emergency room visits and hospitalizations.
However, the agency is not free to make “allow-use” recommendations for boosters, because of the EUA terms that doctors can provide additional doses to vulnerable patients.
The updated terms provide greater freedom for the CDC and its Advisory Committee on Immunization Practice (ACIP) to recommend more doses of bivalent vaccines. ACIP will hold a meeting on the Covid-19 vaccine on Wednesday and is expected to endorse the changes in the FDA.
For everyone who is not covered by today’s changes, the FDA said it intends to make a decision on future vaccination after receiving a recommendation for autumn strain composition from its advisory committee in June.
Both Canada and U.K. This spring, people with the highest risk of Covid-19 have provided another round of bivalent boosters.
