It has been a good week for leading COVID-19 vaccine makers, Pfizer PFE /BioNTech BNTX and Moderna MRNA, with a string of positive news.
The European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") has granted a positive opinion for a 30-µg booster dose of Pfizer's/BioNTech's Omicron BA.1 bivalent COVID-19 vaccine. CHMP recommended conditional marketing authorization of the booster dose for individuals 12 years and older. It also gave a positive opinion recommending authorization for the use of Moderna's Omicron-targeting bivalent booster in the European Union.
The positive recommendations for these boosters come in anticipation of a surge in COVID-19 infections in the upcoming winter season. The original vaccines developed by these companies helped countries combat the pandemic in record time. However, their lack of efficacy against emerging variants of the virus was a concern. Hence, the regulatory bodies had urged the companies to advance a bivalent vaccine candidate to make an Omicron-adapted vaccine available to various countries as soon as possible.
The European Commission will take the recommendations into account, and a quick decision is expected shortly, given the imminent potential need.
Pfizer's/BioNTech's Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15-µg of mRNA encoding the spike protein in the original vaccine with 15-µg of mRNA encoding the spike protein of the Omicron BA.1 variant. The CHMP recommendation is based on safety, tolerability and immunogenicity data from a phase II/III trial of the Omicron BA.1-adapted bivalent vaccine.
Both companies have also filed an application to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine. This application is currently under review.
Moderna's next-generation bivalent vaccine candidate also contains mRNA-1273 and a vaccine candidate targeting the Omicron BA.1 variant.
Earlier in the week, the FDA granted emergency use authorization (EUA) to PFE/BNTX's Omicron BA.4/BA.5-adapted vaccine as a booster for ages 12 and older. Moderna's BA.4/.5 Omicron-targeting bivalent COVID-19 booster vaccine (mRNA-1273.222) was authorized for adults 18 years and older.
The Centres of Disease Control and Prevention has also recommended these updated boosters (adding Omicron BA.4 and BA.5 spike protein components to the current vaccine composition) from Pfizer/BioNTech and Moderna for the targeted age groups, respectively, to recoup the waning immunity from previous vaccination by targeting more transmissible variants and immune-evading.
Moderna has already received approval for Omicron-targeting bivalent boosters in the United States, Australia, Switzerland and the U.K.
Meanwhile, CHMP has recommended Novavax's NVAX Nuvaxovid COVID-19 vaccine for expanded conditional marketing authorization in the EU as a booster for adults aged 18 and older. The authorization could allow Nuvaxovid to be used as a booster regardless of previous vaccine history.
Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally and is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster.
While the world, in general, seems to have managed the pandemic quite well post the roll-out of vaccines and their boosters, emerging variants do pose a cause of concern, and prevention is better than cure in this regard.
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