Novavax: Large study finds COVID-19 shot about 90% effective
Updated 5:21 p.m. on June 14, 2021
MILWAUKEE, Wis. (CBS 58) - On Monday, Novavax announced promising results in what could be a fourth coronavirus vaccine to be approved in the U.S. with a 90-percent overall efficacy in its U.S./Mexico trials, but with vaccines already being widely available in the area, is there a need for another one?
"You know it probably wouldn't be as critical to get this one approved for emergency use as it was for Pfizer and Moderna early on where we just didn't have any options," said Dr. Jeff Pothof, Chief Quality Officer at UW Health.
The company says its U.S./Mexico trials of their two-dose vaccine recruited nearly 30,000 people, resulting in 90-percent overall efficacy and 100-percent protection from severe disease. Novavax says they do plan to apply for Emergency Use Authorization in the third quarter.
"Since they were kind of part of Operation Warp Speed and are kind of just the last ones to come to the table, I don’t know if the FDA will consider them for emergency use," Dr. Pothof adds. "The emergency in the Emergency Use Authorization is starting to lighten up because we already have supply. They may say go for full FDA approval you know that could take 8 months to a year even on an accelerated timeline."
Dr. Pothof says the Novavax vaccine is different than the three vaccines currently approved for use in the U.S., it has a synthetic protein and adjuvant to trigger an immune response.
"It's a little bit different technology but technology that's used in modern flu vaccines, Hepatitis B vaccines and HPV vaccines," he said.
He says while a fourth vaccine may not be as beneficial in the U.S. for first doses, it could prove to be useful once boosters are needed.
"If all of a sudden we have 300 million people who need a booster, well at that point if you can get a Johnson and Johnson, Pfizer, Moderna or Novavax booster, that might make the process of getting boosters much quicker," Dr. Pothof said.
Dr. Pothof says the Novavax vaccine proved to be near 90-percent effective against the UK or 'Alpha' variant but only about 50-percent effective against the South African or 'Beta' variant.
"Right now the virus is moving faster than the global distribution of vaccines," said Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization during a briefing on Monday.
Dr. Pothof believes the Novavax vaccine would likely be used in other countries before it's distributed here.
"I think they would probably look to apply to other countries as a priority because I mean that's where their vaccine is needed and that's likely where it could be used," he adds.
"Available evidence suggests new variants have substantially increased transmission globally, that means the risks have increased for people who are not protected, which is most of the world's population," says Dr. Tedros Adhanom Ghebreyesus. "To end the pandemic our shared goal must be to vaccinate at least 70-percent of the world's population."
As far as safety, Dr. Pothof says he doesn't think the safety profile of the Novavax vaccine will be any better than current COVID-19 vaccines in the U.S., but does say the technology does have more of a track record.
Published: 5:44 a.m. on June 14, 2021
By LINDA A. JOHNSON
Vaccine maker Novavax said Monday its shot was highly effective against COVID-19 and also protected against variants in a large, late-stage study in the U.S. and Mexico. The vaccine was about 90% effective overall and preliminary data showed it was safe, the company said.
While demand for COVID-19 shots in the U.S. has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world.
That help is still months away, however. The company says it plans to seek authorization for the shots in the U.S., Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.
“Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Novavax Chief Executive Stanley Erck told The Associated Press.
While more than half of the U.S. population has had at least one COVID-19 vaccine dose, less than 1 percent of people in the developing world have had one shot, according to Our World In Data. study involved nearly 30,000 people ages 18 and up in the U.S. and Mexico.
Two-thirds received two doses of the vaccine, three weeks apart, and the rest got dummy shots.
There were 77 cases of COVID-19 — 14 in the group that got the vaccine and the rest were in volunteers who received dummy shots. None in the vaccine group had moderate or severe disease, compared to 14 in the placebo group.
The vaccine was similarly effective against several variants including the one first detected in the U.K. that’s dominant in the U.S., and in high-risk populations including the elderly and people with other health problems.
Side effects were mostly mild — tenderness and pain at the injection site.
There were no reports of unusual blood clots or heart problems, Erck said.
Novavax reported the results in a press release and plans to publish in a medical journal, where it will be vetted by independent experts.
The Maryland-based company previously released findings from smaller studies in Britain and South Africa.
COVID-19 vaccines train the body to recognize the coronavirus, especially the spike protein that coats it, and get ready to fight the virus off.
The Novavax vaccine is made with lab-grown copies of that protein.
That’s different from some of the other vaccines now widely used, which include genetic instructions for the body to make its own spike protein. The Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
Novavax previously announced manufacturing delays due to supply shortages. The company now expects to reach production of 100 million doses a month by the end of September and 150 million doses a month by December.
The company has committed to supplying 110 million doses to the U.S. over the next year and a total of 1.1 billion doses to developing countries. In May, vaccines alliance Gavi announced it had signed an agreement to buy 350 million doses of Novavax’s vaccine, with deliveries estimated to begin in the third quarter. COVAX, the global initiative to provide vaccines to countries, is facing a critical shortage of vaccines after its biggest supplier in India suspended exports until the end of the year, Novavax has been working on developing vaccines for more than three decades, but hasn’t brought one to market.
The company’s coronavirus vaccine work is partly funded by the U.S. government.