Reuters/Agents – FDA scientists on Tuesday (Oct. 12) said the drug company Moderna. Inc. does not qualify for all permissions on the necessity. “Covid-19 booster vaccine” or the 3rd dose because the original two doses of the Moderna vaccine are effective enough to still prevent disease.
Reuters reported on Tuesday (Oct. 12) that a U.S. Food and Drug Administration scientist said in the document that The data for the Moderna vaccine show that The stimulation needle can add protective antibodies. However, the difference in pre- and post-injection antibody levels was not large, especially among those who still had high antibody levels.
“Some real-world studies on the effectiveness of vaccines have shown that Over a period of time, Moderna’s COVID-19 vaccine was less effective against symptomatic or delta virus infections. Other studies have pointed to no,” an FDA expert said in a 45-page document released on the FDA’s website on Tuesday.
and also said that “However All in all, the data indicates that a US-licensed or licensed COVID-19 vaccine can still be effective in preventing critical phases of COVID-19 and death in the United States,” according to the report. From CNBC US media
Previously for Pfizer-Biontech’s booster vaccine FDA officials have not sided with Pfizer’s booster vaccine in the past month. But that hasn’t stopped the Vaccines and Related Biological Products Advisory Committee from recommending a third dose vaccine.
The document was released ahead of an upcoming meeting of an external expert advisory committee this week to consider the booster vaccine.
Most of the time, the FDA will follow the advice of its own experts, but not necessarily. And the U.S. Centers for Disease Control and Prevention’s CDC advisory committee will meet next week to discuss which groups will be able to receive the booster vaccine if the FDA allows it.
Pharmaceutical company Moderna Inc. wants the green light to allow a 50 microgram booster vaccine, which is weaker than the regular COVID-19 vaccine given in two doses four weeks apart.
Moderna wants to allow the booster vaccine for older people over 65 and in vulnerable groups similar to those at competing drug companies. Pfizer-Biontech received
CNBC pointed out that Moderna Pharmaceuticals filed for a booster vaccine with the US FDA on Sept. 1, the company said. The results from the clinical trials of 170 adult volunteers, which are fewer than the 318 Pfizer clinical trials used for the booster vaccine studies.
Moderna said The 50% sub-dose booster vaccine is safe and can produce a stronger immune response than seen after the second dose in the Phase 3 clinical trials.
As for the side effects for Moderna’s booster vaccine, it was found that It was similar to those received after the second dose, the company said in a document released by the US FDA on Tuesday. low risk
and Moderna reported that Rare heart disease problems were not found. myocarditis (Myocarditis) or pericarditis. (Pericarditis) in the subjects during 29 days after receiving the booster needle.
The FDA advisory committee will consider Moderna’s booster vaccine Thursday (14) and Friday (15) for consideration of a booster vaccine for Johnson & Johnson Pharmaceuticals. or J&J, which the company has not released a brief document about its own booster vaccine.
Johnson & Johnson Company has asked the FDA to allow a booster dose of the vaccine to people who received a single dose of COVID-19 vaccine two months earlier. The company said The data suggests that high-risk adults should get the booster vaccine early. But for those at lower risk, boosters should be given at least 6 months apart.
CNBC reports it is expected that after the meeting, the FDA will release the results of the approval a few days later.
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