FDA Grants Full Approval of Moderna’s COVID-19 Vaccine

February 02, 2022 - FDA fully approves Moderna’s mRNA COVID-19 vaccine, Spikevax, for individuals 18 years of age and older.

"The full licensure of Spikevax in the US now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the US FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.

In December 2020, FDA granted emergency use authorization to Spikevax. And in October, the agency granted a third dose of the vaccine at the 100 microgram dose level in immunocompromised adults who had undergone solid organ transplantation or were diagnosed with chronic conditions.

FDA based its approval on the totality of scientific evidence shared by the company in its submission package, which included follow-up data from the Phase COVE study showing high efficacy and favorable safety nearly six months after the second dose.

So far, over 70 countries have approved Spikevax.

Novavax Submits EUA Request to FDA for COVID-19 Vaccine

Novavax recently submitted a request to FDA for emergency use authorization of its COVID-19 vaccine, NVX-CoV2373.

The company based the request on the totality of pre-clinical, clinical, and manufacturing-related (CMC) data, including two pivotal Phase clinical trials. PREVENT-19 enrolled 30,000 participants in the US and Mexico, and the second trial enrolled nearly 15,000 participants in the UK.

In both trials, NVX-CoV2373 demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low and balanced between vaccine and placebo groups.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley C. Erck, president and CEO of Novavax, said in the press release.

“I'd like to also extend our thanks for the support of the US Department of Health and Human Services and the US Department of Defense for their partnership leading up to today's milestone of EUA request submission,” Erck concluded.

Merck, Ridgeback COVID-19 Treatment Helps Effective Against Omicron

Merck and Ridgeback Biotherapeutics recently announced data from six preclinical studies demonstrating that its COVID-19 treatment, molnupiravir, was effective against the Omicron variant.

Researchers from Belgium, Czech Republic, Germany, Poland, the Netherlands, and the US conducted the in vitro studies. The studies used cell-based assay to evaluate the antiviral activity of molnupiravir and other COVID-19 antiviral agents against SARS-CoV-2 variants of concern.

Molnupiravir showed consistent antiviral activity against the Omicron variant in all of the trials, providing additional confidence of treatment potential in adults with mild to moderate COVID-19.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including Omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” Wendy Holman, chief executive officer of Ridgeback, said in the announcement.

“We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic,” Holman continued.