The Food and Drug Administration (FDA) on March 29 amended the emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow a second booster shot for individuals ages 50 and older and immunocompromised individuals.
Individuals ages 50 and older may receive a second dose of the Pfizer or Moderna vaccine at least four months after receiving a first booster dose of any approved or authorized vaccine.
FDA authorized a second booster shot of the Pfizer vaccine at least four months after a first booster for individuals ages 12 and older who have undergone a solid organ transplant or have a health condition that causes a similar level of immunocompromise. A second booster shot of the Moderna vaccine is authorized four months after the first booster for individuals ages 18 and older with the same level of immunocompromise.
The agency cites data from an ongoing, open-label, nonrandomized clinical study of health care workers in Israel. Among individuals who received a second booster shot at least four months after the first booster shot, neutralizing antibody levels against the SARS-CoV-2 virus, including delta and omicron variants, increased two weeks after the second booster compared with five months after the first booster dose.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet April 6 to discuss considerations for variant-specific vaccines and the timing and populations for booster doses. Notably, VRBPAC will not vote or discuss product-specific applications.
OSHA Reopens Comment Period for Emergency Temporary Standard
The Occupational Safety and Health Administration (OSHA) on March 23 reopened the public comment period on its COVID-19 emergency temporary standard (ETS) for the health care industry.
Initially published in June 2021, the ETS aims to protect those working in health care settings where patients with suspected or confirmed COVID-19 infection are treated. America’s Essential Hospitals commented on the ETS in August 2021, expressing concerns with its implementation timeline and scope.
In December 2021, OSHA withdrew the non–record keeping portions of the ETS after failing to issue a permanent standard in the time allotted. The COVID-19 log and reporting provisions remain in effect.
The reopened public comment period runs through April 22. OSHA will hold an informal, virtual public hearing on April 27; those interested in providing oral testimony or documentary evidence at the hearing must file a written notice of intention to appear by April 6. The agency plans to release a final standard later this year.
Moderna to Seek EUA for Pediatric Vaccines
Moderna announced March 23 it plans to submit a request to the FDA in in the coming weeks for EUA of a low-dose COVID-19 vaccine for children ages six months to under six years. Each dose in the two-dose primary vaccination series would contain 25 micrograms, one-quarter of the adult dose.
Additionally, Moderna has initiated an EUA submission of its vaccine for children aged 6–11, who would receive a primary series of two 50-microgram doses. The company also is updating its EUA submission for adolescents ages 12–17 with follow-up data.
FDA Limits Sotrovimab Authorization
FDA on March 25 deauthorized the use of sotrovimab, a monoclonal antibody treatment, in select regions, citing a high frequency of the omicron BA.2 subvariant and data showing sotrovimab is unlikely to be effective against the subvariant.
Sotrovimab, initially authorized in February 2022, no longer may be administered in:
- U.S. Health and Human Services (HHS) Region 1: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont; and
- HHS Region 2: New Jersey, New York, Puerto Rico, and the Virgin Islands.
The BA.2 subvariant is estimated to account for more than 50 percent of COVID-19 cases in these regions. As a replacement, FDA recommends Paxlovid, Veklury (remdesivir), bebtelovimab, and Lagevrio (molnupiravir), which are expected to be effective against BA.2. The agency has released a fact sheet for health care providers about this decision.
CDC Clarifies COVID-19 Mask Guidance
Following media reports that hospitals and health care facilities were asking patients and visitors to replace or cover their N95 masks with a surgical mask, the Centers for Disease Control and Prevention updated its clinical guidance to recommend that “people visiting health care facilities use the most protective form of source control that fits well and may be worn consistently.”
The new guidance also states health care facilities may choose to offer well-fitting face masks as a source control option for visitors but should allow patients and visitors to choose to wear a clean mask or respirator with a higher level of protection.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.