Today (March 28, 2022), the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This makes a second booster dose of both vaccines available to other populations at higher risk for severe disease, hospitalization and death.
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”
The FDA amended the emergency use authorizations as follows:
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
- A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
The FDA changes apply only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The FDA plans to continue evaluating data and information as it becomes available when considering the potential use of a second booster dose in other age groups.
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).
Hopkins County, Texas Vaccine Statistics
According to Texas Department of State Health Services, 76.52% of Texans age 5 years and older (20,634,296) had received at least one dose of COVID-19 vaccine, including 17,419,881 who are fully vaccinated, and 6,502,643 Texans who’d received a booster dose of the vaccine.
In Hopkins County, 48.3% of residents ages 5 and older had received at least one dose of the vaccine, including 42.58% who were fully vaccinated. Among the population age 65 and older in Hopkins County, 70.25% of residents were reported to be fully vaccinated, and 76.36% had received at least one dose of COVID-19 vaccine.
Overall, that’s 16,728 people age 5 and older in Hopkins County who’ve received at least one dose of the vaccine; 14,747 reported to be fully vaccinated for COVID-19 and 5,250 who’ve had a booster dose of the COVID vaccine.
People ages 16-49 accounted for 5,367 of the people reported to be fully vaccinated in Hopkins County, more than any other age group. Next were people ages 50-64 (3,924), then ages 65-79 (3,645 people); ages 80 and older (1,193); ages 12-15 (420 people), and finally ages 5-11, who were fully vaccinated in Hopkins Couty, according to the March 28, 2022 Texas Health and Human Services/DSHS report.
Also, women continue to outpace men for full vaccinations in every age category except juveniles 15 and younger; 101 boys and 92 girls ages 5-11 years are fully vaccinated in Hopkins County, 215 boys and 205 girls ages 12-15 were reported to be fully vaccinated. A total of 7,869 White people in Hopkins County (53.36%) had been fully vaccinated, 3,041 people (20.52%) who listed their race or ethnicity as “Other,”2,380 Hispanic (16.14%), 816 Blacks (5.53%), 509 whose race and ethnicity was listed as “Unknown” (3.45%) and 132 Asian residents (0.9%),
Information to Support Authorization of a Second COVID-19 Booster Dose
The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations. The evidence considered for authorization of a second booster dose following primary vaccination and first booster dose included safety and immune response information provided to the agency as well as additional information on effectiveness submitted by the companies.
A summary of safety surveillance data provided to the FDA by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 4 months after the third dose in adults 18 years of age and older (approximately 600,000 of whom were 60 years of age or older) revealed no new safety concerns.
The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech COVID-19 Vaccine and safety information reported from an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety concerns were reported during up to three weeks of follow up after the second booster dose.
Immunogenicity data from an ongoing, open-label, non-randomized clinical study in healthcare workers at a single center in Israel were reported in a publication provided to the FDA. In this study, individuals 18 years of age and older who had received primary vaccination and a first booster dose with Pfizer-BioNTech COVID-19 Vaccine were administered a second booster dose of Pfizer-BioNTech COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120 individuals) at least four months after the first booster dose. Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose.
The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.
