COVID-19 Vaccines in the USA
The U.S. Food and Drug Administration (FDA) has issued three Emergency Use Authorizations for COVID-19 vaccines. The U.S. FDA Approved the Comirnaty COVID-19 vaccine (Pfizer-BioNTech) on August 23, 2021.
And as of September 24, 2021, the FDA continues Authorizing Modern'a mRNA vaccine SpikeVax and COVID-19 Vaccine Janssen from Johnson & Johnson.
In Europe, the European Medicines Agency has Authorized four COVID-19 vaccines and is reviewing five others. Globally, over 100 COVID-19 vaccine candidates are undergoing clinical trials reported GAVI.
NOTES:
The U.S. CDC reported data on September 23, 2021, representing about 55% of the US population had been fully vaccinated with an Authorized COVID-19 vaccine.
On September 22, 2021, Ruth Link-Gelles, Ph.D., MPH, presented 'COVID-19 Vaccine Effectiveness in the United States' to the U.S. CDC's vaccine committee.
Sara Oliver M.D., MSPH, presented Updates to COVID-19 Epidemiology and COVID-19 Vaccines during the U.S. FDA's VRBPAC Meeting on September 17, 2021. Dr. Oliver's presentation indicates the Delta virus variant has significantly reduced COVID-19 protection against infection (including asymptomatic or mild infections) in recent months. Dr. Oliver also presented 'Evidence to Recommendation Framework' during the CDC's vaccine committee meeting on September 23, 2021.
COVID-19 vaccines effectively prevent mild symptoms, severe disease, and hospitalizations due to COVID-19 disease. But it is still possible for a fully vaccinated person to become infected if exposed to the SARS-CoV-2 betacoronavirus. The CDC reported fatal COVID-19 vaccine Breakthrough Cases reached 2,675 as of September 7, 2021. However, after collecting data on thousands of vaccine breakthrough infections from States, the CDC changed the focus of how it uses/discloses data on May 1, 2021.
As of September 8, 2021, the CDC confirmed myocarditis or pericarditis cases in all ages/age groups. Previously, during the CDC's ACIP meeting on June 23, 2021, Tom Shimabukuro, M.D., Vaccine Safety Team, presented 'Early safety data of myocarditis or pericarditis among Pfizer-BioNTech vaccination in persons aged 12–15 years old.'
And the CDC's ACIP committee (Dr. Julia Gargano) confirmed on August 30, 2021, 'Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome, thrombosis with thrombocytopenia syndrome after Janssen COVID-19 vaccination, and myocarditis after Comirnaty vaccination.
As of September 9, 2021, the UK's Medicines and Healthcare products Regulatory Agency had received Adverse Drug Reaction reports to the Comirnaty (Pfizer - BioNTech), Vaxzevria (COVID-19 Vaccine AstraZeneca), and for the SpikeVax COVID-19 Vaccine (Moderna). Furthermore, Public Health England reported Probable COVID-19 Breakthrough reinfections had been identified.
Search vaccines.gov, text your zip code to 438829 or call 1-800-232-0233 to find COVID-19 vaccine locations near you in the USA.
