Boston, Massachusetts 2021-09-23 16:20:34 –
NS The Vaccine Advisory Board voted Thursday recommending that a wide range of Americans be provided with Covid-19 vaccine booster shots at least 6 months after the second vaccination.
The Advisory Committee on Immunization and Implementation (ACIP) recommends providing booster jabs to adults 65 years and older with a 15-0 vote, and providing booster doses to 50-64 people with underlying health conditions. Was recommended by a vote of 13-2. conditions.
In another vote, the panel left the door open to people aged 18-49 years with underlying medical conditions taking booster shots, based on a “benefit and risk” assessment. This is a phrase that traditionally means suggesting a conversation between individuals. And its healthcare providers.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, must approve the recommendations. She is expected to do so on Thursday, and the booster shot program could start shortly, the week set by the Biden administration as a goal.
Based on ACIP’s recommendations, many adults will soon have access to the Covid vaccine booster, but only those who have been vaccinated with Pfizer and BioNTech vaccines as the primary series are eligible to receive the booster. Nearly 100 million people in the United States have been vaccinated twice with the Pfizer vaccine.
At the end of Wednesday, the Food and Drug Administration announced “unavoidable exposure” to the SARS-CoV-2 virus for people over the age of 65, and for health conditions or “frequently” institutional or occupational environments.
Many ACIP members questioned whether the Commission should allow Moderna or Johnson & Johnson vaccinated people to seek Pfizer boosters. However, the FDA said there was no data to conclude that a third dose of another vaccine was as effective as a third dose of the original vaccine.
Peter Marks, director of the FDA’s vaccine division, told the Commission that the FDA understands complaints about not being able to give boosters to those who did not receive the Pfizer vaccine at this time. He said the agency is working with manufacturers to try to fill this gap as soon as possible.
Most members of the committee supported the use of boosters, but there were some concerns that this step would not resolve the country’s Covid problem. Keipp Talbot, a vaccine researcher at Vanderbilt University, said the hospital was full of unvaccinated Covid-19 people, and boosting fully vaccinated people wouldn’t change that.
“I feel like we’re putting lipstick on a pig,” she said. “This is not going to solve the pandemic.”
Thursday’s ACIP vote suspends a rocky five-week period when the Biden administration finds it in conflict with many in the scientific community and those who evaluate drug and vaccine approvals that follow regulatory channels. To do.
Rather than seeking advice from the FDA and CDC on whether it’s time for Americans to make booster shots available, the government has announced that the booster shot campaign will begin in the week of September 20th. The announcement was made before the booster shot took place. It is licensed and before two of the three manufacturers apply for booster approval to the FDA.
Whether most fully vaccinated people need booster shots at this point remains the point of heated debate. Data from Israel, one of the first countries to vaccinate most of the population quickly, suggest that the Pfizer vaccine’s ability to protect itself from serious illnesses subsides within a few months. Many questions remain about the interpretation of the data. Also, since Israel used only the Pfizer vaccine, the country’s experience tells us nothing about the other vaccines used.
The FDA’s Vaccine Advisory Board, Vaccine and Related Biological Products Advisory Board, or VRBPAC for short, voted at a meeting last Friday not to recommend booster immunization for anyone over the age of 16 who received the Pfizer vaccine. bottom. Instead, we recommended providing boosters to a small number of individuals, including those over the age of 65 and those at high risk of severe illness.
Pfizer applied for approval for a booster offered to people over the age of 16 and was given 6 months after the second dose of the vaccine.
In creating an emergency use authorization for Pfizer boosters, the FDA took advantage of the ambiguity of VRBPAC voting to significantly increase the number of people eligible for booster shots.
In addition to adults aged 65 and over, anyone over the age of 18 who is at high risk of severe covid due to high risk of exposure to the SARS-CoV-2 virus due to health or work can get a booster .. This means people with a variety of medical conditions, such as pregnancy, diabetes, obesity, or high blood pressure. Similarly, health care workers, teachers, day care workers, people working in grocery stores, or people living or working in homeless shelters or prisons can receive boosters.
It also includes people who live with people with weakened immunity, as interpreted by the CDC. Studies have shown that people with weakened immunity are often unprotected with two doses. In August, the FDA expanded its approval for the Pfizer and Modana vaccines to allow boosters for people with severely weakened immunity. However, even with the third dose, some vaccine protection is limited.
There is considerable overlap between these groups. Anyway, these groups could total more than 100 million Americans, but at this time, only some of the Pfizer-vaccinated groups are eligible for boosters.
One group that did not cut was 16 and 17 years old. Pfizer’s application did not contain data to support the safety of giving boosters to ages 16 and 17. Members of VRBPAC also strongly opposed including them without safety data. After all, the FDA did not include them.
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