“1. Executive Summary: …
The proposed use under an EUA is ‘for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.’ …
2. Background
2.3. U.S. Requirements to Support Issuance of an EUA for a Biological Product: …
In the event an EUA is issued for this product, it would still be considered unapproved and it would be under further investigation…
5.2.6 Safety
Serious Adverse Events ...
Suspected COVID-19 Cases
Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study
population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected
COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine
group vs. 287 in the placebo group...
Subgroup Analyses
Pregnancies: Female study participants of childbearing potential were screened for pregnancy prior to each vaccination, with a positive test resulting in exclusion or discontinuation from study vaccination… Pregnancy outcomes are otherwise unknown at this time.
8.2 Unknown Benefits/Data Gaps
Duration of Protection: As the interim and final analyses have a limited length of follow-up, it is not possible to assess sustained efficacy over a period longer than 2 months…
Vaccine effectiveness against mortality: A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality.
Vaccine effectiveness against transmission of SARS-CoV-2: Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination… Additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.
8.4 Unknown Risks/Data Gaps
Safety in certain subpopulations: There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.
Vaccine-enhanced disease. Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.”