American biotech company Moderna’s mRNA Covid-19 vaccine has been added to the World Health Organization’s (WHO) basket of vaccines for emergency use. It became the fifth vaccine available to countries participating in the COVAX facility. It had already got a nod from the US Food and Drug Administration (FDA) last year.
WHO Approves Moderna Vaccine For Emergency Use, Pfizer Vaccine for Teenagers
The WHO said Moderna’s vaccine (mRNA 1273) has been listed for emergency use, making it the fifth to receive such validation from WHO. Others that are already approved include Pfizer’s mRNA vaccine, the AstraZeneca-Oxford University vaccine from two different suppliers, including the Serum Institute of India, and the one-dose Johnson and Johnson vaccine.
WHO’s Emergency Use Listing (EUL) assesses the quality, safety, and efficacy of Covid-19 vaccines and is a prerequisite for the COVAX facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines, the agency explained.
The vaccine has already been reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), making recommendations for vaccines’ use in populations (i.e., recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above.
The US Food and Drug Administration (USFDA) had issued an emergency use authorization for the Moderna vaccine in December 2020 and a marketing authorization valid throughout the European Union was granted by the European Medicines Agency in January 2021.
The Moderna vaccine is an mRNA-based vaccine. It was found by the SAGE to have an efficacy of 94.1 percent, based on a median follow-up of two months. Although the vaccine is provided as a frozen suspension at –25 ºC to –15 ºC in a multidose vial, vials can be stored refrigerated at 2–8 °C for up to 30 days prior to the withdrawal of the first dose, meaning that ultra-cold chain equipment may not always be necessary to deploy the vaccine, the WHO said, a significant feature in different climatic regions and in low and middle-income countries that may not have the infrastructure to store and distribute.
The FDA is all set to authorize Pfizer/BioNTech’s coronavirus vaccine in children and teens ages 12 to 15 by early next week, according to sources. The FDA is currently reviewing data submitted by Pfizer to support the extended use. Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100%, and it is well tolerated. The vaccine is currently authorized in the US for emergency use in people 16 and older.
Pfizer and Moderna both are testing their vaccines in children as young as six months and expect to ask the FDA for EUAs covering infants and children later this year.
Maryland-based Novavax, meanwhile, announced Monday it has expanded its Phase 3 trial for its Covid-19 vaccine to include up to 3,000 children ages 12 to 17 across the United States. They will receive the vaccine candidate or placebo in two doses 21 days apart. Novavax’s Covid-19 vaccine is not yet authorized for emergency use in the United States.