FDA approves protein-based Covovax vaccine for emergency use in Thailand

Need a Covid jab? If you’re in Thailand, you’ll have a new option. The Food and Drug Administration has approved the protein-based Covovax vaccine manufactured by Novavax for active immunisation against Covid-19.

The FDA granted the vaccine emergency-use authorisation for individuals 18 years of age and older last Friday, according to a press release from Novavax. The vaccine — known officially as NVX-CoV2373 — is manufactured and marketed under the brand name Covovax.

The FDA’s decision was based on the preclinical, manufacturing and clinical trial data submitted for review. US-based biotechnology company Novavax has conducted two pivotal Phase 3 clinical trials.

One trial, PREVENT-19, included 30,000 participants aged 18 years and older in the US and Mexico and the results were published in the New England Journal of Medicine. Another trial was conducted with almost 15,000 adult participants in the UK, the results of which were also published in the same journal.

In both trials, the vaccine demonstrated “efficacy, safety and tolerability”. Serious and severe adverse reactions were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed were headache, nausea, vomiting, myalgia, arthralgia, injection site tenderness, fatigue and malaise.

The vaccine’s safety will continue to be monitored while it is distributed in Thailand. Novavax president and chief executive officer, Stanley Erck, hailed the FDA’s acceptance of the new vaccine, saying…

“Novovax looks forward to delivery of the first protein-based Covid-19 vaccine option for the people of Thailand… We remain committed to helping fight the global pandemic by offering an additional vaccination option built on a well-understood platform used in other vaccines for decades.”

Covovax has also been approved for emergency use authorisation in Indonesia, the Philippines, Bangladesh and India, where it’s authorised for use in children aged 12 – 18 years old. The vaccine has also received Emergency Use Listing from the World Health Organisation. However, the US FDA has not yet approved the vaccine for use in the US.

SOURCE: Novavax