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The FDA and the Medicines and Healthcare products Regulatory Agency, the UK regulator, have different processes to review vaccines, Dr. Penny Ward, a visiting professor in pharmaceutical medicine at King's College London, told The New York Times.

The FDA asks drugmakers for raw data, which it reanalyzes, while British regulators rely more heavily on reports produced by the drugmakers.

The UK has approved a COVID-19 vaccine, but the US is still waiting. Here's why.

MEXICOWANDERER wrote:

They have independent consultation. The USA demands the minutes taken at every vaccine developer meeting. Then everything is highly subject to leakage to foreign entities. The USA government FDA LEAKPROOF? surely you jest.

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Prespecified subgroup analyses are not included in this report but will be presented in future analyses when a larger dataset is available. However, in response to reviewer and editorial comments, a small number of exploratory subgroup comparisons has been included to explore differences in efficacy in the LD/SD and SD/SD groups and potential confounder variables. The LD/SD cohort in the UK comprised participants aged 18–55 years who received their second dose after a substantial gap. Age and the time difference between vaccines were therefore potential confounders and were explored further in subgroup analyses, restricted to those aged 18–55 years, those with more than 8 weeks’ interval between vaccine doses, and a comparison of those in the SD/SD cohort receiving vaccines at short (<6 weeks) or long (?6 weeks) intervals. Subgroup comparisons were done by incorporating the treatment-by-subgroup interaction term in the model and reporting the p value for the interaction term.

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The timing of priming and booster vaccine administration varied between studies. As protocol amendments to add a booster dose took place when the trials were underway, and owing to the time taken to manufacture and release a new batch of vaccine, doses could not be administered at a 4-week interval. 1459 (53·2%) of 2741 participants in COV002 in the LD/SD group received a second dose at least 12 weeks after the first (median 84 days, IQR 77—91) and only 22 (0·8%) received a second dose within 8 weeks of the first. The median interval between doses for the SD/SD group in COV002 was 69 days (50–86). Conversely, the majority of participants in COV003 in the SD/SD group (2493 (61·0%) of 4088) received a second dose within 6 weeks of the first (median 36 days, 32–58; appendix 1 p 11).

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After phase 1 results supported a two-dose regimen, the trial protocols were amended where necessary to require two standard doses (SD/SD cohort) of approximately 5?×?1010 viral particles per dose administered 28 days apart, but a subset (LD/SD cohort) in one of the UK trials inadvertently received a half-dose of the vaccine (low dose) as the first dose before a change in dosage quantification methodology; additionally, the protocol amendments enabled other trial participants originally scheduled to receive a single dose to receive a booster more than 28 days after their first dose.