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FDA authorizes Pfizer / BioNTech and Moderna Coronavirus Vaccine Boosters for all adults

FDA authorizes Pfizer / BioNTech and Moderna Coronavirus Vaccine Boosters for all adults

 


Authorities have extended the emergency use authorization for booster doses of both mRNA vaccines beyond those who were previously eligible. Boosters were approved for people over the age of 65 who were vaccinated with the Pfizer or Moderna vaccine at least 6 months ago, and for certain adults at high risk of infection or serious illness.

Pfizer and BioNTech last week requested approval based on the results of a phase 3 study involving more than 10,000 participants. Boosters were found to be safe and 95% effective against symptomatic Covid-19 compared to a two-dose schedule during the period when the highly infectious Delta was the predominant strain. Pfizer released booster effect data last month. It has not been peer-reviewed or published yet.

Moderna requested approval of a 50 microgram booster dose for all adults on Wednesday. According to the company, the FDA created the EUA based on “whole scientific evidence shared by the company,” including data showing that neutralizing antibodies declined in about six months.

Recent real-world studies have suggested that the Covid-19 vaccine may begin to weaken immunity and may reduce protection, especially against mild asymptomatic diseases. Studies have shown that booster doses restore that immunity.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said recent data from Israel show that among people over the age of 60, boostered people are more severe than vaccinated people. He told CNN that it was unlikely to happen. I haven’t received a booster. The incidence of severe illness remained the highest among unvaccinated individuals.

“Through the course of the COVID-19 pandemic, the FDA has endeavored to make timely public health decisions as the pandemic progresses. The COVID-19 vaccine is the best and most effective defense against COVID-19. A single booster dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine to individuals over the age of 18 provides ongoing protection against COVID-19, including serious consequences such as hospitalization and death. Helps to provide. Commissioner Dr. Janet Woodcock said in a statement.

The Centers for Disease Control and Prevention’s Vaccine Advisory Board will meet on Friday to discuss booster eligibility. After the recommendation is approved by CDC Director Dr. Rochelle Walensky, the booster may be formally administered to all adults.

However, the majority of adults are already eligible for boosters, and some states have already officially opened boosters to all adults.

“Everyone is qualified”

Expanding booster qualifications to all adults in the United States may not change the logistics of using ammunition as a weapon.

Vaccine supply for boosters is already in place in many places. There are no “additional steps” that need to take place on the part of the booster rollout management, Adrian Casalotti, Head of Government and Public Relations for the National Association of County and Municipal Health Officials, told CNN.

“There are enough vaccines nationwide. There are many places with reservations. Obviously, some areas are more in demand than others, so it depends a little on where you live geographically.” Casalotti told CNN.

Frustrated Biden officials want to simplify Covid-19's message with a booster decision

“But that said, I think the main preparation is on the communication side,” Kazarotti added. “Contacting local health providers and public health departments means that if someone asks if they need to get a booster, they don’t have to worry about their qualifications. This is information-everyone 6 Eligible after a month. “

According to CDC data, more than 32 million people in the United States (about 16% of fully vaccinated people) have been boosted with the Covid-19 vaccine.

According to CDC data, approximately 18 million elderly people have been boosted with the Covid-19 vaccine, accounting for more than half of all boosts received and one-third of fully vaccinated elderly. Increases one or more immune responses.

However, more than twice as many elderly people (about 40 million people over the age of 65) completed their first vaccine series at least 6 months ago. Less than half comply with the current CDC guidance on who should get a booster.

What’s next?

The CDC Vaccine Advisors Meeting begins at noon on Friday and may be signed off by Warensky at any time after the advisor’s vote.

The CDC Vaccine Advisor last met in October to discuss the Covid-19 booster shot.

“We’re looking at what we’ve seen up to weakened immunity and what we’ve seen in terms of Covid rates compared to about a month before the discussion first took place,” said Dr. Marci Dreams. increase. Delaware-based ChristianaCare’s chief infection control officer and hospital epidemiologist told CNN on Thursday.

Drees is the Society for Healthcare Epidemiology of America, which keeps in touch with the CDC’s Immunization Implementation Advisory Board.

According to Johns Hopkins University, the United States currently has an average of 94,943 new Covid-19 cases daily. This is a 31% increase from last week and is back to the level seen over a month ago. Midwestern states account for more than one-third (38%) of new cases.

There are concerns that winter weather, which drives people indoors and for holiday gatherings, can lead to even more cases.

“So we certainly want people to be as well protected as they could enter the season,” Dolly’s said. “For many who were vaccinated last winter and spring, I think it’s time for their protection to be weakened.”

After people receive the Covid-19 vaccine booster shot, it is not clear when they need to get another vaccine.

“It’s certainly a matter of millions of dollars. We know that boosters will bring people’s immunity back to its 90% to 95% range in the short term. I don’t know how long it will last. “Drees said.

“In a sense, we are paving the way for new things, much of which is driven by whether we can immunize the population well and really stop further infections,” Dreams said. I am saying. “We know that boosters do not end a pandemic. Boosters will help and prevent people from getting sick, but we still give people first and second doses. Need to be promoted. “

CNN’s Deidre McPhillips contributed to this report.

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