The first month of COVID-19 vaccine safety monitoring found relatively few adverse events, according to a CDC report published Feb. 19 in MMWR. From Dec. 14, 2020, to Jan. 13, 2021, more than 13 million doses were administered. During that time, 6,994 adverse events were reported to the national database. Of those, 90.8% were classified as nonserious. The most frequent were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). More reactions were reported after the second dose of Pfizer-BioNTech than the first (data on the second dose of the Moderna vaccine were not available). There were 62 confirmed reports of anaphylaxis, 46 after receipt of the Pfizer-BioNTech vaccine and 16 after receipt of the Moderna vaccine. A total of 113 deaths were reported after vaccination, and information from death certificates, autopsy reports, medical records, and clinical descriptions did not suggest a causal relationship. “These initial findings should provide reassurance to health care providers and to vaccine recipients and promote confidence in the safety of COVID-19 vaccines,” the CDC said.
In other vaccine news, the Advisory Committee on Immunization Practices (ACIP) released its 2021 Recommended Adult Immunization Schedule, including interim recommendations for COVID-19 vaccines. The schedule was published Feb. 11 by Annals of Internal Medicine and on the CDC website.
Following the FDA's emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines, ACIP issued interim recommendations supporting their use on Dec. 12, 2020, and Dec. 19, 2020, respectively. Changes in recommendations for other vaccines include the following.
Influenza. For the 2020-2021 flu season, routine annual influenza vaccination is recommended for those ages 6 months and older who do not have contraindications. There is no preference among products.
Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccination (Tdap). In the notes, the language for wound management was updated and states that for patients with three or more doses of tetanus toxoid-containing vaccine who have clean and minor wounds, administer Tdap or Td if more than 10 years have passed since the last dose of tetanus toxoid-containing vaccine. For all other wounds, administer Tdap or Td if more than five years have passed since last dose of tetanus toxoid-containing vaccine. Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown. If a tetanus toxoid-containing vaccine is indicated for a pregnant woman, use Tdap.
Hepatitis A. In the notes, under Travel in Countries with High or Intermediate Endemic Hepatitis A, language was added for the accelerated Twinrix schedule. HepA-HepB combination vaccine or Twinrix may be administered on an accelerated schedule of three doses at 0, 7, and 21 to 30 days, followed by a booster dose at 12 months.
Hepatitis B. In the notes under Special Situations, language was added that the choice of hepatitis B vaccination for persons with diabetes ages 60 years or older should be made via shared clinical decision-making.
Meningococcal A, B, C, W, Y vaccination. In the notes, bullets regarding booster doses were added that makes recommendations for groups listed under Special Situations and for outbreak settings, as well as among men who have sex with men.
Pneumococcal vaccination. Under Shared Clinical Decision-Making, the bullets were reordered:
- PCV13 and PPSV23 should not be administered during the same visit.
- If both PCV13 and PPSV23 are to be administered, PCV13 should be administered first.
- PCV13 and PPSV23 should be administered at least 1 year apart.
The ACIP guidance notes that it is important for all adults to receive recommended immunizations and catch-up vaccines during the pandemic, while wearing masks and following personal hygiene and social distancing measures.