FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine for Children Ages 5 to 11
The FDA approved the emergency use of a two-dose regimen (10 mcg each) of Pfizer/BioNTech’s COVID-19 vaccine for children 5 through 11 years of age. The authorization was based on the FDA’s evaluation of data and input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. The FDA’s advisory committee concluded that the benefits of the Pfizer/BioNTech’s COVID-19 vaccine outweighed the risks of the vaccine in this population.
Before the vaccine can be made available, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet next week to evaluate the data. If the CDC recommends and the CDC Director approves the vaccination for this age group, the vaccine will become available in the near future.
The data submitted to the FDA in their application for use of the Pfizer/BioNTech’s COVID-19 vaccine for the 5- to 11-year-old age group show a robust antibody response and favorable safety outcomes in children ages 5 to 11 who received the two-dose regimen in clinical trials. In the phase 2/3 trial (2,268 participants), children received two vaccine doses of 10 mcg, less than the two 30-mcg doses used in an earlier successful trial for people 16 to 25 years old. The smaller dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity, according to Pfizer/BioNTech. Adverse events were similar to other populations, with no cases of myocarditis or pericarditis, anaphylaxis, or deaths.
The companies noted that new cases in children in the United States continue to be at a high level. From September 16-30, 2021, there was a 7% increase in the cumulated number of COVID-19 cases in children since the beginning of the pandemic. To date, children represent 16% of the total cumulated COVID-19 cases. For the week ending September 30, 2021, children under age 18 accounted for approximately 27% of all weekly COVID-19 cases in the United States.
FDA Authorizes Moderna and Johnson & Johnson COVID-19 Vaccine Boosters; Allows “Mix and Match” of Different COVID-19 Vaccines for Booster
The FDA expanded the use of a booster dose for COVID-19 vaccines in eligible populations and is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
- The use of a single booster of Moderna COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
- The use of a single booster dose of Johnson & Johnson COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
- The use of each of the available COVID-19 vaccines as a heterologous (“mix and match”) booster dose may be administered in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
The FDA clarified that a single booster dose of the Pfizer/BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
Merck Seeks FDA Approval of Its Antiviral Pill for COVID-19
Merck applied to the FDA for emergency use authorization (EUA) for molnupiravir, its investigative oral antiviral COVID-19 treatment of mild to moderate COVID-19 in adults who are at risk of having severe COVID-19 or being hospitalized. Molnupiravir is a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
If FDA grants the EUA, molnupiravir would be the first approved oral antiviral COVID-19 treatment.
Interim data from Merck’s global phase 3 clinical trial showed that molnupiravir reduced the risk of hospitalization or death by about 50%. In the study, approximately 7% of patients who received the drug were hospitalized within 30 days, compared with 14% of patients who took a placebo. No deaths were reported in the group that received the drug, compared with eight deaths in the group that received placebo. None of the trial participants had been vaccinated.
Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
