The Food and Drug Administration (FDA) on Jan. 31 granted full approval for Moderna’s COVID-19 vaccine. The vaccine now will be marketed as Spikevax for individuals age 18 and older and is the second FDA-approved vaccine, following the Pfizer vaccine in August 2021.
The Moderna vaccine has been available since December 2020 under an emergency use authorization (EUA). It remains available under the EUA as a third primary series dose for immunocompromised individuals age 18 and older and as a single booster dose for individuals age 18 and older at least five months after completing a primary series of COVID-19 vaccine.
In granting approval, FDA analyzed updated data from 14,287 vaccine recipients and 14,164 placebo recipients ages 18 and older who did not have evidence of SARS-CoV-2. Spikevax was 93 percent effective in preventing COVID-19, with 55 cases occurring in the vaccine group and 744 cases in the placebo group, and 98 percent effective in preventing severe disease.
FDA also evaluated post-authorization safety surveillance data for myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) after receipt of the Moderna vaccine. Data show increased risks within seven days following the second dose, with the highest risk in men ages 18 to 24. FDA’s benefit-risk assessment determines the benefits of the vaccine outweigh the risks, and Moderna’s Spikevax prescribing information includes a warning about these risks. FDA is requiring Moderna to conduct postmarketing studies to assess the risks of myocarditis and pericarditis following vaccination. Moderna also has committed to additional studies, including one focused on pregnancy and infant outcomes.
CDC Study: Omicron Variant Strains Health Systems
The omicron variant of SARS-CoV-2 is now the dominant variant in the United States, accounting for 99.5 percent of cases as of Jan. 15. A study published in the Centers for Disease Control and Prevention’s (CDC’s) Morbidity and Mortality Weekly Report shows the high volume of emergency department (ED) visits and hospitalizations continues to strain U.S. health care systems, although disease severity appears lower with the omicron variant than with previous variants,
The highest daily seven-day moving average of cases to date (798,976 daily cases from Jan. 9–15), ED visits (48,238), and admissions (21,586) were reported during the omicron period, according to data from health departments, the National Syndromic Surveillance Program, and the Unified Hospital Data Surveillance System.
However, during the omicron period, ratios of ED visits, hospitalizations, and deaths to cases observed were lower than in previous periods, as were disease severity indicators, including intensive care unit admission, receipt of invasive mechanical ventilation, length of stay, and in-hospital death, among hospitalized patients. This decrease in severity is likely due to increases in vaccination and receipt of vaccine boosters during this period.
The study underscores the importance of emergency preparedness, including hospital surge capacity and staffing ability, in responding to COVID-19, as well as the importance of vaccination in reducing severity.
The World Health Organization (WHO) is monitoring a subvariant of the omicron variant. BA.2, which differs from BA.1 in the spike protein and in other mutations and has been detected in multiple countries. WHO says investigations into the characteristics of BA.2, including immune escape properties and virulence should be prioritized independently, and comparatively, to BA.1.
OSHA Withdraws COVID-19 Vaccine ETS
Effective Jan. 26, the Occupational Safety and Health Administration (OSHA) withdrew its Nov. 5, 2021, emergency temporary standard (ETS) encouraging large employers to promote widespread vaccination.
The ETS required companies with 100 or more employees to implement a COVID-19 vaccine mandate or require employees to wear a face mask and submit to weekly testing. OSHA is withdrawing the ETS after evaluating the U.S. Supreme Court’s Jan. 13 decision to block the mandate.
While OSHA is withdrawing the ETS as an enforceable standard, the agency continues to strongly urge vaccination of workers to protect against COVID-19 in the workplace.
FDA Limits Monoclonal Antibody Authorization
FDA on Jan. 24 narrowed the EUAs for two monoclonal antibody treatments that data show are highly unlikely to be active against the omicron variant.
Because the omicron variant currently is dominant, bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) are not currently authorized for use in any U.S. states, territories, and jurisdictions.
These monoclonal antibodies previously were authorized for adults and pediatric patients (12 years of age and older and weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19. Treatment use may be authorized in the future if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments.
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.