Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Dec 22. 2021 – Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Continue reading

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

November 19, 2021: Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.Continue reading

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

FDA Press Release:  October 29, 2021 – Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.Continue reading

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

For Immediate Release:
October 20, 2021
Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:Continue reading

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study

At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died

Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide

If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19Continue reading