Large study finds COVID-19 shot about 90% effective

June 14, 2021
FILE - Novavax says its vaccine appears effective against COVID-19 in a large study, including against variants. Results from the study in the U.S. and Mexico were released on Monday, June 14, 2021. (AP Photo/Alastair Grant, File)

Vaccine maker Novavax said Monday its COVID-19 shot was highly effective against the disease and also protected against variants in a large study in the U.S. and Mexico, potentially offering the world yet another weapon against the virus at a time when developing countries are desperate for doses.

The two-shot vaccine was about 90% effective overall, and preliminary data showed it was safe, the American company said. That would put the vaccine about on par with Pfizer’s and Moderna’s.

While demand for COVID-19 shots in the U.S. has dropped off dramatically and the country has more than enough doses to go around, 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 supplies in poor parts of the world.

That help is still months away, however. The company, which has been plagued by raw-material shortages that have hampered production, said it plans to seek authorisation for the shots in the U.S., Europe and elsewhere by the end of September and will 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 CEO Stanley Erck said.

While more than half of the U.S. population has had at least one vaccine dose, less than 1% of people in the developing world have had one shot, according to a data collection effort run in part by the University of Oxford.

The Novavax shot stands to become the fifth Western-developed COVID-19 vaccine to win clearance. The Pfizer, Moderna and Johnson & Johnson vaccines are already authorised for use in the U.S. and Europe. Europe also uses AstraZeneca’s formula.

A study underway in Britain is testing which of several vaccines, including Novavax’s, works best as a booster shot for people who received the Pfizer or AstraZeneca formula. Industry analyst Kelechi Chikere said the Novavax shot could become a “universal booster” because of its high effectiveness and mild side effects.

Novavax’s study involved nearly 30,000 people ages 18 and up. 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, the rest in volunteers who received the dummy shots. None in the vaccine group had moderate or severe disease, compared with 14 in the placebo group. One person in that group died.

The vaccine was similarly effective against several variants, including the one first detected in Britain that is 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.

“This is a huge milestone for our company and hopefully for the world,” he said.

Novavax reported the results in a news release and plans to publish them in a medical journal, where they will be vetted by independent experts. The Gaithersburg, Maryland-based company previously released findings from smaller studies in Britain and South Africa.

COVID-19 vaccines train the body to recognise 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.

As for the shortages that delayed manufacturing, Erck said those were due to restrictions on shipments from other countries. “That’s opening up,” he said, adding that Novavax now has weeks’ worth of needed materials in its factories, up from just one week.

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.

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