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On December 10, the FDA will hold a meeting of the Vaccines and Biologics Advisory Committee (VRBPAC) to review BNT162b2, a candidate new crown vaccine jointly developed by Pfizer/BioNTech.
, the FDA published on its official website an internal scientist's assessment of BNT162b2's Emergency Use Authorization (EUA) application.
this is a comprehensive and in-depth assessment of its clinical trial data following the announcement by Pfizer/BioNTech that the new mRNA-based vaccine is up to 95% protected in Phase 3 clinical trials.
the FDA say BNT162b2 shows good protection and safety.
It is worth mentioning that further analysis of clinical data shows that the BNT162b2 vaccination programme, although 21 days apart, was vaccinated twice, but began to show protective effects about 10 days after the first vaccination.
, and its protective effectiveness is highly consistent among people of different ages, ethnicities, and carrying different risk factors.
Assessment of protective effectiveness In terms of COVID-19 protection against symptoms, BNT162b2 has a 94.6% effectiveness, 95.0% of participants aged 16-55 years and 93.8% of participants over 55 years of age, showing that it can also provide good protection for the elderly.
, BNT162b2 also exhibits very consistent protective effects in other risk sub-groups.
For example, among obese (BMI)30 participants, its protective effectiveness was 95.5%, and among participants who also had stable underlying complications (including cancer, cardiovascular disease, chronic lung disease, diabetes, obesity), BNT162b2 was 95.3%.
older adults and people with underlying co-virulent disease are among those most likely to be infected with the new coronavirus, and the performance of BNT162b2 means that these high-risk groups receive similar protection to others.
The number of COVID-19 cases in which symptoms appeared in the vaccine and control groups was observed, although the BNT162b2 vaccination process was 21 days apart and 2 doses were given, the rate of accumulation of COVID-19 patients in the vaccine group and the control group began to differ about 10 days after the first dose of the vaccine was given.
analysis showed that BNT162b2 had a protective effect of 52.4% between the first and second doses of vaccine.
But FDA scientists point out that while these data show that BNT162b2 provides a degree of protection after a dose of vaccine, it does not prove that just one dose of vaccine provides long-term protection. The rate of accumulation of COVID-19 cases in the
vaccine group (blue line) and control group (red line) increased significantly between the two groups of cases about 10 days after the first inoculation (Photo source: Reference 1) In protecting patients with severe COVID-19, a total of 4 cases of severe COVID-19 patients in the vaccine group and control group were found after 7 days of 2 doses of vaccination.
of severe patients in the vaccine group was 93% in the air environment, meeting pre-set severe standards.
the patient did not require hospitalization, did not receive any further treatment, and did not have any risk factors for serious illness.
's assessment of vaccine safety Because the new crown vaccine will be given to millions of healthy people, its safety and tolerance are also a concern for scientists.
FDA report, adverse events caused by BNT162b2 were mainly reactions at the injection area (84.1 percent of participants), fatigue (62.9 percent), headache (55.1 percent), chills (31.9 percent), joint pain (23.6 percent) and fever (14.2 percent).
, fever, fatigue and other systemic adverse events occur more frequently after a second dose of the vaccine.
(SAE) reported in the vaccine group was 0.6 per cent and in the control group 0.5 per cent.
some SAEs were not considered by researchers to be related to vaccination, such as appendicitis cases (8) in the vaccine group (8 cases) were higher than in the control group (4).
FDA report noted that adverse events that may be related to the vaccine included swollen lymph nodes, 64 cases in the vaccine group and 6 cases in the control group.
, there were 3 cases of Bell's palsy in the vaccine group and no symptoms in the control group.
bell's palsy is a facial nerve paralysis that causes sudden weakness or paralysis on one side, and most patients, whether treated or not, can fully recover within a few months.
the FDA say Bell's palsy occurs as often as it does in the general population.
review by the FDA found no evidence that the new crown vaccine causes vaccine-enhanced disease.
the reviewers also noted that vaccine-enhanced diseases may occur when immunity declines, and that it still needs to be evaluated in on-going clinical trials, as well as in approved observational studies.
documents provided today by the FDA will serve as the basis for the Advisory Committee's discussions on December 10.
BNT162b2 be supported by the Advisory Committee, further from obtaining FDA emergency use authorization? Let's wait and see.
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