This is the real information needed to make an inf
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Posted On: 12/09/2020 12:06:22 PM
This is the real information needed to make an informed Covid vaccine consent. https://www.fda.gov/media/144245/download
Below are a few direct excerpts from the document that I found interesting.
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.
Effectiveness in certain populations at high-risk of severe COVID-19
Although the proportion of participants at high risk of severe COVID-19 is adequate for the overall evaluation of safety in the available follow-up period, the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy outcomes.
Future vaccine effectiveness as influenced by characteristics of the pandemic, changes in the virus, and/or potential effects of co-infections
The study enrollment and follow-up occurred during the period of July 27 to November 14, 2020, in various geographical locations. The evolution of the pandemic characteristics, such as increased attack rates, increased exposure of subpopulations, as well as potential changes in the virus infectivity, antigenically significant mutations to the S protein, and/or the effect of co-infections may potentially limit the generalizability of the efficacy conclusions over time. Continued evaluation of vaccine effectiveness following issuance of an EUA and/or licensure will be critical to address these uncertainties.
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. However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent disease-associated death.11-14 Benefits in preventing death should be evaluated in large observational studies following authorization.
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. Demonstrated high efficacy against symptomatic COVID-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake, though it is possible that if efficacy against asymptomatic infection were lower than efficacy against symptomatic infection, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission. 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
8.3. Known Risks
The vaccine has been shown to elicit increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days. The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Adverse reactions characterized as reactogenicity were generally mild to moderate. The number of subjects reporting hypersensitivity-related adverse events was numerically higher in the vaccine group compared with the placebo group (137 [0.63%] vs. 111 [0.51%]). Severe adverse reactions occurred in 0.0-4.6% of participants, were more frequent after Dose 2 than after Dose 1 and were generally less frequent in older adults (>55 years of age) (<2.8%) as compared to younger participants (≤4.6%). Among reported unsolicited adverse events, lymphadenopathy occurred much more frequently
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.
Adverse reactions that are very uncommon or that require longer follow-up to be detected
Following authorization of the vaccine, use in large numbers of individuals may reveal additional, potentially less frequent and/or more serious adverse events not detected in the trial safety population of nearly 44,000 participants over the period of follow up at this time. Active and passive safety
I found (but could have missed) no reference in the document to what happened in England https://nypost.com/2020/12/09/uk-issues-warni...9-vaccine/. Maybe this is one of those 8.4 Unknown Risks/Data Gaps. It looks like, to me, that England will end up being the real Phase 3 study. Glad to have another six month of data collection before I even qualify to get the vaccine.
Below are a few direct excerpts from the document that I found interesting.
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.
Effectiveness in certain populations at high-risk of severe COVID-19
Although the proportion of participants at high risk of severe COVID-19 is adequate for the overall evaluation of safety in the available follow-up period, the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy outcomes.
Future vaccine effectiveness as influenced by characteristics of the pandemic, changes in the virus, and/or potential effects of co-infections
The study enrollment and follow-up occurred during the period of July 27 to November 14, 2020, in various geographical locations. The evolution of the pandemic characteristics, such as increased attack rates, increased exposure of subpopulations, as well as potential changes in the virus infectivity, antigenically significant mutations to the S protein, and/or the effect of co-infections may potentially limit the generalizability of the efficacy conclusions over time. Continued evaluation of vaccine effectiveness following issuance of an EUA and/or licensure will be critical to address these uncertainties.
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. However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent disease-associated death.11-14 Benefits in preventing death should be evaluated in large observational studies following authorization.
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. Demonstrated high efficacy against symptomatic COVID-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake, though it is possible that if efficacy against asymptomatic infection were lower than efficacy against symptomatic infection, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission. 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
8.3. Known Risks
The vaccine has been shown to elicit increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days. The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Adverse reactions characterized as reactogenicity were generally mild to moderate. The number of subjects reporting hypersensitivity-related adverse events was numerically higher in the vaccine group compared with the placebo group (137 [0.63%] vs. 111 [0.51%]). Severe adverse reactions occurred in 0.0-4.6% of participants, were more frequent after Dose 2 than after Dose 1 and were generally less frequent in older adults (>55 years of age) (<2.8%) as compared to younger participants (≤4.6%). Among reported unsolicited adverse events, lymphadenopathy occurred much more frequently
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.
Adverse reactions that are very uncommon or that require longer follow-up to be detected
Following authorization of the vaccine, use in large numbers of individuals may reveal additional, potentially less frequent and/or more serious adverse events not detected in the trial safety population of nearly 44,000 participants over the period of follow up at this time. Active and passive safety
I found (but could have missed) no reference in the document to what happened in England https://nypost.com/2020/12/09/uk-issues-warni...9-vaccine/. Maybe this is one of those 8.4 Unknown Risks/Data Gaps. It looks like, to me, that England will end up being the real Phase 3 study. Glad to have another six month of data collection before I even qualify to get the vaccine.
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