FDA approves Novavax Covid-19 vaccine

The FDA declined to comment, and people with knowledge of the matter warned that the plan could still change.

Novavax, a biotech company headquartered in Maryland, is due to complete the final round of quality assurance reviews of its vaccine over the next few days. But the Biden administration purchased 3.2 million doses of the vaccine earlier this week in anticipation that the vaccine would soon be greenlit by the agency.

The pending approval comes after two years of setbacks for Novavax, once considered one of the most promising Covid vaccine developers. The Trump administration went as far as pre-ordering 110 million doses of the vaccine in 2020, investing $1.6 billion in the process.

But the company, which has never produced a successful vaccine before, encountered a number of production problems and fought for months to comply with US regulatory standards, far behind the pace set by competitors.

Meanwhile, the FDA has cleared vaccines from Moderna, Pfizer-BioNTech and Johnson & Johnson, as well as hundreds of millions of shots for the Biden administration’s vaccination campaign. Since then, the agency has approved Covid vaccines for everyone six months and older, as well as several boosters and received full approval to the Pfizer vaccine for children aged 12 years.

As Novavax prepares to launch its first shots in the US, other vaccine makers are working with administration officials to decide on reformulated vaccine boosters that better target the mutating virus and are expected to be distributed later this fall.

However, the Novavax vaccine is offering a fourth option at a time when White House officials are emphasizing that immunizations and boosters are key to preventing a severe infection that can lead to hospitalization or death, even if the BA.4 and BA.5 strain sub-options Omicron infections predominate throughout the country.

“As we see the rise of BA.5 across the country, we encourage all Americans to get vaccinated if they haven’t already,” White House coordinator Ashish Jha said at a press briefing Tuesday.

In June, an external advisory committee of FDA experts voted 21 to 0 with one abstention to recommend that the agency authorize the Novavax vaccine. In late-stage clinical trials involving more than 25,000 people in the US and Mexico, the vaccine was found to be more than 90 percent effective in preventing Covid-19 infections and 100 percent effective in preventing hospitalizations.

The Novavax vaccine uses an older technology than other Covid-19 vaccines: a recombinant protein derived from moth cells. The company’s trials were conducted when the predominant strain was the alpha variant of the coronavirus. Although the company provided the FDA with updated data, including on the effectiveness of the Omicron variant vaccine, that data was not available to external consultants at the time of their vote.

Once the FDA officially approves the Novavax shot, approval from the Centers for Disease Control and Prevention is still required, which usually happens quickly.