Breaking News: The FDA Advisory Board unanimously recommends booster doses of Moderna’s COVID-19 vaccine to people over the age of 65 who are at high risk for an underlying illness or work.
- The FDA’s advisory board unanimously voted to recommend approval of Covid booster shots of Modana’s vaccine on Thursday.
- Booster shots are only approved for people over the age of 65 who are at high risk for work or underlying illness
- One month after Pfizer’s COVID-19 vaccine booster was approved by the same risk group.
- Moderna, released last month, shows that people who received the COVID-19 vaccine last year are almost twice as likely to develop a breakthrough infection.
The US Food and Drug Administration (FDA) Advisory Board has resolved to recommend approval for a booster dose of Moderna’s COVID-19 vaccine.
Boosters are only approved for the elderly over 65 years of age, those at high risk of developing severe cases of the virus due to underlying illness, and at least 6 months after the second dose.
Almost exactly one month after the Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) approved the booster immunization of the Pfizer-BioNTech vaccine.
Many VRBPAC members lamented the lack of more robust data to support the need for boosters, but those who point out that the precedent has already been set by approving Pfizer’s third shot. There was also.
Dr. Stanley Perlman, a professor of microbiology and immunology at the university, said, “From a practical point of view, I have already approved it at Pfizer, so I don’t think it may not be approved at Modana.” I am. Iou said during the meeting.
The FDA’s advisory board voted to recommend approval of Covid booster shots of Moderna’s vaccine.Photo: Healthcare workers holding a Vial of Moderna COVID-19 vaccine in New York City, January 2021
Unlike Pfizer’s booster, which is the third dose of the vaccine, Moderna’s booster has a dose of 50 micrograms (µg), half the dose of the original vaccine.
Previous data show that boosters increased the levels of neutralizing antibodies. This includes those for the original virus and variants, including beta and gamma variants.
The advisory board also examined data from Israel, which started Pfizer booster administration two and a half months ago.
The data showed that boosters reduced the number of severe cases in people over the age of 60 by 84 percent from 957 to 150.
Booster also reduced severe cases by 95% for patients aged 18 to 49 years from 160 to 7 years and for patients aged 16 to 39 years from 23 to 1 year.
Last month, Moderna released data showing that people who received the COVID-19 vaccine last year are almost twice as likely to develop a breakthrough infection as those who were recently vaccinated.
There were 88 breakthrough cases of COVID-19 among Americans vaccinated between December 2020 and March 2021.
By comparison, 162 patients (1.8 times) were vaccinated between July 2020 and December 2020.
A company based in Cambridge, Massachusetts said the data provided evidence to give booster doses to fully vaccinated people.
In August, the COVID-19 Vaccine Booster Shot will be rolled out for all Americans from September 20th at the White House.
At that time, the Biden administration published a study citing the ability of delta mutants to cause weakened immunity and breakthrough infections.
However, FDA and US Centers for Disease Control and Prevention (CDC) officials objected, saying there was not enough evidence that the vaccine was less effective.
During the VRBPAC meeting, members reiterated that the data did not show reduced vaccine efficacy, especially in healthy people under the age of 65.
Dr Archana Chatterjee, an infectious disease expert at Rosalind Franklin University and dean of the Chicago Medical College, said:
“The disease appears to occur primarily in the unvaccinated state, especially in the most severe form.”
As a result, Pfizer’s vaccine booster was not deployed until September 22 (after the target deployment date) and was only deployed to specific groups, such as Moderna.
Second, Moderna booster shots need to be approved by the FDA and approved by the US Centers for Disease Control and Prevention (CDC) Advisory Board.
This is the latest news and will be updated.
FDA Advisory Board recommends booster vaccination with Moderna’s COVID-19 vaccine
Source link FDA Advisory Board recommends booster vaccination with Moderna’s COVID-19 vaccine