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Vaccine maker Novavax said on Monday that its COVID-19 vaccine was highly effective against the disease and also protected against variants in a large study in the United States and Mexico, potentially giving the world yet another weapon against the virus to one. moment when developing countries are desperate. dose.
The two-shot vaccine was around 90% effective overall and preliminary data showed it to be safe, the U.S. company said. This would put the vaccine on par with that of Pfizer and Moderna.
As demand for COVID-19 vaccines in the United States has declined dramatically and the country has enough doses for everyone, 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 increasing supplies in poor regions 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 apply for authorization for injections in the United States, Europe and elsewhere by the end of September and would be able to produce up to 100 million doses per year. months by then.
“A lot of our first doses will go to… low- and middle-income countries, and that was the goal initially,” said Novavax CEO Stanley Erck.
While more than half of the American population has received at least one dose of the vaccine, less than 1% of people in the developing world have received a single injection, according to a data collection effort led in part by the University. from Oxford.
The Novavax shot is set to become the fifth COVID-19 vaccine developed in the West to be cleared. Pfizer, Moderna and Johnson & Johnson vaccines are already authorized in the United States and Europe. Europe also uses the AstraZeneca formula.
The Novavax study involved nearly 30,000 people aged 18 and over. Two-thirds received two doses of the vaccine, three weeks apart, and the rest received sham injections. Almost half of the volunteers were black, Hispanic, Asian American or Native American, and 6% of the participants were in Mexico. A total of 37% had health problems that made them at high risk, and 13% were 65 years of age or older.
There were 77 cases of COVID-19 – 14 in the group that received the vaccine, the rest in the volunteers who received the sham injections. None in the vaccine group had moderate or severe disease, compared to 14 in the placebo group. One person in this group has died.
The vaccine was also effective against several variants, including the one first detected in Britain which is now dominant in the United States, and in high-risk populations including the elderly, people with other health issues and frontline workers in hospitals and meat packing plants. .
“These consistent results give great confidence in the use of this vaccine for the global population,” said Dr Paul Heath, director of the Vaccine Institute at the University of London and St. George’s Hospital.
The side effects were mostly mild – tenderness and pain at the injection site. No cases of blood clots or unusual heart problems have been reported, Erck said.
An ongoing study in Britain is testing which of several vaccines, including that from Novavax, works best as a booster shot for people who have received the Pfizer or AstraZeneca formula. Industry analyst Kelechi Chikere said the Novavax vaccine could become a “universal booster” due to its high efficacy and mild side effects.
Novavax published the results in a press release and plans to publish them in a medical journal, where they will be reviewed by independent experts. The Gaithersburg, Maryland-based company previously released the results of smaller studies conducted in Britain and South Africa.
COVID-19 vaccines train the body to recognize the coronavirus, especially the spike protein that covers it, and prepare to fight the virus. The Novavax vaccine is made from laboratory-grown copies of this protein. This is different from some of the other now widely used vaccines, which include genetic instructions for the body to make its own spike protein.
Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
As for the shortages that have delayed manufacturing, Erck said they were due to restrictions on shipments from other countries.
“It is opening up,” he said, adding that Novavax now has weeks of needed materials in its factories, compared to just one week.
The company has committed to deliver 110 million doses to the United States over the next year and a total of 1.1 billion doses to developing countries.
In May, the Gavi Vaccine Alliance, leader of the UN-backed COVAX project to deliver vaccines to the poorest countries, announced it had signed an agreement to purchase 350 million doses of the Novavax formula. COVAX faces a serious vaccine shortage after its largest supplier in India suspended exports until the end of the year.
Novavax has been working on vaccine development for more than three decades but has not brought one to the market. His work on the coronavirus vaccine is partly funded by the US government.
Dr Peter English, a former British Medical Association vaccine expert, called Novavax’s results “excellent news”. English said that since vaccine production is complicated, it is crucial to have as many vaccines as possible.
“Any minor imperfection in the production plant can stop production for days or weeks,” he said in a statement. “The more different manufacturers we have producing vaccines, the more likely it is that we will have vaccines available. “
He said it was also encouraging news that Novavax would be able to adapt its vaccine to any variant of potential concern in the future if necessary.
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Follow Linda A. Johnson on Twitter: LindaJ_onPharma
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AP Medical Writer Maria Cheng contributed to this report.
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The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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