POTUS, Pandemic is over

The pandemic is over (POTUS)

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Emergency use authorizations

August 31, 2022

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine,

and the Pfizer-BioNTech COVID-19 Vaccine,

to authorize bivalent formulations,

for use as a single booster dose

Original strain + BA.4 and BA.5 lineages

For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence,

including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines,

safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineage

that is similar to each of the vaccines being authorized,

Biden administration

Has already placed an order for 170 million doses

https://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questions

Data collected by the companies

Human data, only available BA.1 booster

BA.1 trails did not look for protection against severe disease, (People trials are very expensive)

For the BA.4/BA.5 boosters, the companies have submitted animal data.

(not released publicly)

Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose, (for EMA)

Showed an increased antibody response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

Clinical trials for the BA.4/BA.5 vaccines will begin this month

August 19, 2022

https://www.fda.gov/news-events/press-announcements/fda-roundup-august-19-2022

Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine,

in individuals 12 through 17 years of age.

This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA.

July 13, 2022

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine,

in individuals 18 years of age and older.