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FDA Panel recommends Moderna COVID-19 booster for high-risk adults




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The leading FDA panel voted 19-0 in favor of the Emergency Use Authorization (EUA) for the Moderna-NIAID COVID-19 vaccine for the elderly and high-risk adults.John Cherry / Getty Images
  • A group of experts voted to recommend boost immunization of the Moderna-NIAID COVID-19 vaccine to the elderly and others at high risk.
  • The recommendations are similar to the Pfizer-BioNTech booster program.
  • Adults aged 65 and over, adults aged 18-64 years at high risk of severe COVID-19, and adults aged 18-64 working in high-exposure occupations are all eligible for the Moderna booster.
  • Additional shots are recommended 6 months after the first second dose.
  • The booster formulation is half the amount of the original sequence, 50 micrograms vs. 100 micrograms.

The Food and Drug Administration’s (FDA) Advisory Board voted unanimously on October 14, recommending that authorities approve booster doses. Moderna-NIAID COVID-19 vaccine For some high-risk US adults.

The recommendations reflect the Emergency Use Authorization (EUA) of. Pfizer-BioNTech Booster, And the following groups.

  • Those over 65 years old
  • People aged 18-64 years at high risk of severe COVID-19
  • People aged 18-64 years at high risk of serious COVID-19 complications due to frequent work-related or institutional exposure to coronavirus

Boosters can be given at least 6 months after the second dose.

In addition, the booster is half the dose used for the first and second doses — 50 micrograms vs. 100 micrograms.

The Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) was 19-0 in support of the Emergency Use Authorization (EUA).

The FDA decides whether to accept the advisory board’s recommendations.

The Centers for Disease Control and Prevention’s Vaccine Advisory Board will then meet to determine which groups should receive the Moderna-NIAID booster.

Data presented during the October 14 meeting show that the COVID-19 vaccine currently approved in the United States continues to protect. Severe illness and death Due to coronavirus.

However, “some actual efficacy studies have suggested reduced efficacy of the modelna COVID-19 vaccine against symptomatic infections or delta variants, while others do not,” the FDA said. Scientists say in a briefing. Document..

The Pfizer-BioNTech and Johnson & Johnson vaccines have also shown some reduction in efficacy against infection in the months following complete vaccination.

In addition, the panel heard from Israeli researchers the latest information on booster campaigns in the country, primarily including the Pfizer-BioNTech vaccine.

Data from Israel show a reduction in COVID-19 cases and serious illness after booster deployment. This effect was most pronounced in people over the age of 60, but it also occurred in younger people.

As more age groups were targeted for boosters, the country saw a decline in overall cases, including those not vaccinated.

“The administration of booster doses has helped Israel mitigate the fourth wave of infections and severe cases,” said Dr. Sharon Alroy-Preis, Head of Public Health Services. Ministry of Health, Israel, Told a member of the committee.

During the meeting, some members also talked about the potential boosters to reduce the long-term health effects of infectious diseases in fully vaccinated people.

“A recently published study found that vaccinated individuals can develop long-term COVID-19 if they experience a breakthrough COVID-19 infection of any severity. ” Dr. Peter Marks, The director of the FDA’s Center for Biopharmaceutical Evaluation and Research said during the meeting.

Moderna’s Phase 2 booster trials were too small to show whether booster doses reduced the risk of infection or severe COVID-19.

Instead, scientists measured neutralizing antibodies in the blood after boosting and compared them to levels after the second dose.

In the study, 171 fully vaccinated adults received booster 6 months after the second vaccination. The booster weighed 50 micrograms, half the first and second doses.

Of these people, 88% confirmed that neutralizing antibody levels increased at least 4-fold. This shows how well the vaccine is protected from infections and illnesses.

People who started with lower antibody levels were more likely to see such a large increase.

However, the difference in immune response between booster and primary was not important enough to meet the company’s definition of success.

Some members of the committee expressed concern about the data submitted by Moderna.

The data itself isn’t strong, but it “certainly points the way” in favor of this EUA committee member. Dr. Patrick Moore, A professor at the University of Pittsburgh Cancer Institute, said during the meeting.

In Phase 2 exams Side effects The booster dose ratio was similar to that after the primary series. The most common were headaches and malaise.

Certain side effects were more common after booster administration.

People under the age of 65 were more likely to have swollen armpit lymph nodes after booster immunization than after the second dose. This was mainly calm and short-lived.

Myalgia and arthralgia were also more common in people over the age of 65 after booster than the second dose.

However, the incidence of these side effects was similar to that seen in the company’s larger phase 3 trials.

One of the side effects that requires continuous monitoring is heart inflammation — Myocarditis and pericarditis..

This is a known side effect of the mRNA vaccine. Previous data show that these conditions are more common after the second dose and in younger men. In most cases it is mild and responds well to treatment.

Moderna’s Phase 2 booster immunological study was not large enough to show the incidence of myocarditis after booster immunization.

The FDA and the US Centers for Disease Control and Prevention (CDC) will continue to monitor people who have been boosted for myocarditis and other side effects.

Preliminary data presented during the meeting by Israeli researchers suggest that the incidence of myocarditis after booster immunization is not higher than after the second dose.

“I am very confident in the serious events,” said Alroy-Preis.

However, Israeli researchers have only long-term follow-up data on about half of the young people who have been boosted. This is the group at high risk of heart inflammation.





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