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FDA scientists neutral on Moderna Covid-19 vaccine booster – Boston, Massachusetts

Boston, Massachusetts 2021-10-12 13:11:11 –

NSScientists at the ood and Drug Administration did not take a clear position in a document released Tuesday as to whether authorities should approve a booster dose of the Moderna Covid-19 vaccine.

Both booster shots were posted prior to the two-day meeting convened by the FDA. Modana When Johnson & Johnson vaccination, document He presented a case for approving the booster immunization proposed by Moderna (half the dose of existing vaccines), but also stated that it was unclear from previous data that a third dose was needed. ..

“Several real-world efficacy studies have suggested reduced efficacy of the Moderna COVID-19 vaccine against symptomatic infections or delta variants, but some do not,” FDA scientists briefed. I am writing in the documentation. However, the current data they wrote suggest that the Covid vaccine available in the United States still protects against severe Covid-19 illness and death.

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At the meeting, a panel of experts will discuss and vote on the booster plans of both companies. Such recommendations are used by the FDA to assist in decision making, but are not binding.

It seems unlikely that the meeting will be repeated Similar panel held last month Decide whether to approve booster shots of the Covid-19 vaccine developed by Pfizer and BioNTech. At the time, the advisory board said it was unpleasant to recommend boosters to people over the age of 16. This is due to the lack of evidence that boosters are needed and the potential risk of myocarditis, pericarditis, and heart inflammation. Although rare, it can be the result of a vaccine, especially in young men.

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However, the panel is now being asked to recommend the same Modana booster approval as Pfizer’s, and the two vaccines are similar. Pfizer boosters are allowed for individuals over the age of 65. People over the age of 18 who are at high risk for severe Covid-19. And those who are at high risk of serious complications of Covid-19 due to frequent institutional or occupational exposure. This last group could include not only health care workers, but also grocery store clerks and prison guards.

Nevertheless, the debate about the risk of myocarditis may prove important. According to FDA documents, most cases of this condition improve spontaneously and appear to occur primarily in young men. An analysis of insurance claim data conducted by the FDA showed that the number of cases for men aged 18 to 25 ranged from 72.4 per million vaccinated to 283.7 per million vaccinated. “It is currently unknown whether the risk of myocarditis / pericarditis or other adverse reactions increases after boosting the Moderna COVID-19 vaccine,” FDA researchers write.

The Commission is also set up to address the question of whether observational data clearly indicate the effectiveness of vaccine decline. Panelists may question the use of half the standard vaccine dose for booster immunization (50 micrograms instead of 100). In a document filed with the FDA, Moderna stated that antibody levels increased 66-fold at both doses, but low doses were unlikely to cause common side effects.

The FDA has not published a briefing document on the Johnson & Johnson Vaccine. In the company’s documentation, J & J claims: Second dose of single dose vaccine Antibody titers have been shown to increase when administered 2 months after the first dose or 6 months after the first dose. While a 2-month regimen has been shown in large clinical trials to prevent severe Covid-19, a 6-month regimen can significantly increase antibody titers.

One of the most interesting topics of the meeting is at the end of the second day. It’s a discussion of a study by the National Institutes of Health looking at what happens when people receive a booster vaccine that is different from what they originally received.Allow such things Mix and match booster It can be much easier to give people shots in the future. It will also open the Covid-19 vaccine market to more players in exchange for giving Pfizer and Moderna an effective lock on the market.



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