“Highly Effective Modern Crown Vaccine” from the US FDA.

Entry 2020.12.15 23:17 | Revision 2020.12.16 00:22

“Meet the recommended criteria for emergency use approval”
18 approval according to Pfizer precedent

The United States Food and Drug Administration (FDA) considered the new vaccine against coronavirus infection (Corona 19) from its national pharmaceutical company Modena through a review report on the 15th (local time) was “highly effective and no special safety concerns were raised. ” , NBC News reported.

This report was prepared in preparation for the FDA External Advisory Group (VRBPAC) meeting scheduled for the 17th. If VRBPAC recommends that the FDA approve the use of the vaccine at a meeting two days later, on the 17th, it is likely that the FDA follow the recommendation.

CNBC reported on the day that “experts reviewed Modena’s Phase 3 clinical results report and determined that it met the FDA’s rush-use approval recommendation criteria in terms of safety.” On the 30th of last month, Modena recently submitted data to the FDA that it had confirmed that more than 94% of the preventive effect had been confirmed in phase 3 clinical trials involving 30,000 people and applied for emergency use approval.

Pfizer’s vaccine, which was previously approved for emergency use in the United States, also went through a similar procedure to the current modder vaccine. On day 8, the FDA released a report indicating that the Pfizer vaccine met recommended criteria, and VRBPAC recommended approval for use two days later. The next day, the FDA made the decision to approve emergency use.

The New York Times (NYT) predicted that the FDA could also approve Modena’s vaccine on the 18th, the day after the VRBPAC meeting.

According to CNBC, the FDA acknowledged that three of Pfizer’s vaccines had symptoms such as paralysis of the facial muscles and “if the vaccine is approved for use, monitoring for this symptom is recommended.” It is difficult to determine the causal relationship between symptoms and symptoms. “