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FILE PHOTO: Screenshot of the FDA meeting Experts discuss this core issue at a meeting of the FDA's Advisory Committee on Vaccines and Related Biologics (VRBPAC) today.
in the final vote, the experts responded positively to the question by a vote of 17 to 4 (with one abstention).
media pointed out that if the FDA accepts experts' recommendations, the vaccine candidate is expected to be approved for emergency use by the FDA as early as tomorrow.
: Screenshot of the FDA meeting Earlier today, the latest trial results of the vaccine were published in the New England Journal of Medicine, a leading medical journal.
, the study recruited 43,548 volunteers over the age of 16 who were divided into two groups who received vaccines or placebo injections on the same day and 21 days of group entry, respectively.
of the 36,523 volunteers who had no evidence of new coronavirus infection, 170 had ended up with neo-coronavirus disease (COVID-19) and developed symptoms (only seven days after the second vaccination).
8 from the vaccine group and 162 from the placebo control group.
based on these data, the researchers analyzed that the vaccine was 95.0 percent effective.
, current data also show that the vaccine has some early protective effect 12 days after the first vaccination.
in terms of safety, the vaccine group is more likely to experience pain, erythema, swelling, fever, headache, and myalgia than the control group, and more after the second vaccination.
most adverse reactions are mild to moderate and can be quickly mitigated.
New England Journal of Medicine also points to the current limitations of the study.
long-term safety and effectiveity has not been clarified because the current data for this trial have a medium follow-up time of only 2 months.
addition, we do not know whether the vaccine is suitable for groups that are not included in clinical trials, such as children, pregnant women, and people with immunodeficiency.
, the statistical criteria in the trial were for new crown patients with symptoms.
we don't know if the vaccine is effective in reducing asymptomatic infections or the spread of the virus to unvaccinated individuals.
, we don't know how to deal with individuals who only get the first shot and don't get the second shot.
the answers to these questions can only be obtained through further research.
, the cumulative number of new crown infections worldwide is close to 70 million.
we look forward to more vaccine products for the world's people to provide protection at an early time, let our lives return to normal! References: s fernando P. Polack et al., (2020), Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine, NEJM, DOI: 10.1056/NEJMoa2034577 (Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine, Retrieved December 10, 2020, from (3) BREAKING: Advisory recommend FDA authorize Pfizer-BioNTech vaccine, opening door to rapid EUA, Retrieved December 10, 2020, from [4] FDA Panel Recommends Approval of Pfizer's Covid Vaccine for Emergency Use, Retrieved December 10, 2020, from。