Novavax's COVID Vaccine Shines in Latest Trial

MONDAY, June 14, 2021 (HealthDay News) -- Novavax, a Maryland biotechnology company that has struggled mightily with delays in developing its coronavirus vaccine, announced Monday that its two-shot regimen was over 90% effective overall in a trial that unfolded even as more contagious variants emerged.

Among 30,000 volunteers — all of them from either the United States or Mexico — vaccinated people were completely protected against severe and even moderate cases of illness. There were no cases of hospitalization or death among people who received the vaccine, the company reported. Side effects were mild — fatigue, headaches and muscle pain — and reactions tended to be less frequent than those triggered by some already authorized vaccines, the company said.

"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines," Novavax president and CEO Stanley Erck said in a statement. "These clinical results reinforce that [the vaccine] is extremely effective and offers complete protection against both moderate and severe COVID-19 infection."

Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said, "It's really very impressive," noting that the vaccine was as good as the most effective shots developed so far during the pandemic. "It's very important for the world's population to have, yet again, another highly efficacious vaccine that looks in its trial to have a good safety profile," Fauci told the Washington Post.

As heartening as the results were, the vaccine may not become a key player in the pandemic until late summer or fall.

Erck told the Post that Novavax will apply for regulatory clearance from a half-dozen countries in the third quarter, which begins in July. With tens of millions of doses already in hand, the company plans to boost manufacturing to produce 100 million doses a month by the end of September and 150 million doses a month in the last three months of the year.

In the United States, the company still needs to file for emergency authorization. The data, which was presented in a news release, will be examined by regulators at the U.S. Food and Drug Administration and by an advisory committee of vaccine advisers. Erck said the vaccine will likely have its biggest initial impact globally, through the World Health Organization's COVAX initiative.

"A lot of our vaccine is going to be targeted in the early stages for COVAX … and so a lot of those doses are going to get into the low- and middle-income countries first, which is a good thing," Erck said. Novavax has pledged 1.1 billion doses to COVAX.

The Novavax vaccine was one of six candidates the U.S. government made a huge bet on, investing $1.6 billion to pay for research and development and preordering 110 million doses, the Post reported.

In January, a large U.K. trial showed it was nearly 90% effective, even once a more transmissible variant had taken hold. Over the past five months, health officials and scientists have waited anxiously for confirming evidence from the U.S. trial. But that second study did not start until the end of December, due in part to manufacturing delays.

Meanwhile, the United States had secured more than enough shots from the three companies with authorized vaccines — Pfizer, Moderna and Johnson & Johnson — to satisfy demand. A fourth, from AstraZeneca, reported results in March.

Recombinant protein vaccines such as Novavax's — the hepatitis B vaccine is another example — teach the immune system to recognize a virus by introducing a lab-made version of a viral protein.

Once the production process is in place, the vaccine offers potential advantages.

"The benefit of their formulation … is it's remarkably scalable, so they can scale to a very high number of doses," Matthew Frieman, a coronavirus expert at the University of Maryland's School of Medicine who has worked with the company in the past, told the Post. "It's not a super-strange production platform … you don't need super-specialized facilities. It's stable, so you don't need severe cold chain" to store the vaccine, he said.

Biden says US may donate another billion COVID vaccine doses next year

President Joe Biden vowed on Sunday to continue sending vaccines to countries in need, adding that the United States may be able to donate a billion more doses to countries in need next year.

Noting that he did not want to make commitments before they were finalized, he said that his administration may "be in a position to provide another billion" doses over the next two years, the Post reported. Last Thursday, Biden announced the United States had purchased 500 million doses of the Pfizer vaccine to send to low- and middle-income countries.

Biden said the G-7 leaders agreed that wealthy democracies need to continue to assist the world in vaccinating the global population, stressing the threat the virus poses as it continues to spread.

"It is also the correct thing to do in terms of our own health, our own security," he said. "You can't build a wall high enough to keep out new strains."

The G-7 leaders, who met over the weekend in England, agreed to help countries with the logistics of vaccinating their citizens while assisting them in building the capacity to manufacture vaccines, the Post reported.

"There was a clear consensus among all our colleagues at the G-7 that this wasn't the end," Biden said. "We were going to stay at it until we're able to provide for the needs of the whole world."

Biden's promise came as the coronavirus death toll in the United States neared 600,000, although new infection rates and hospitalizations have remained low.

In California, the state will fully reopen its economy and lift most social distancing curbs on Tuesday, after having administered more than 40 million vaccine doses.

"It's been a long road, but our future is BRIGHT," Gov. Gavin Newsom said in a Sunday tweet.

Starting June 15, all capacity and physical distancing restrictions will be lifted statewide, though people who have not been vaccinated will still be required to wear a mask in many indoor situations, the Post reported. Either a negative test or proof of inoculation will be required for indoor events that host over 5,000 people, according to the state's Public Health Department.

The state is home to San Francisco, where over 80% of eligible people have received at least one vaccine dose, giving it one of the highest inoculation rates of any large American city. Over 46% of California's 39.5 million residents have been fully vaccinated, according to Post data.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccinations.

SOURCE: Washington Post