COVID-19 vaccine: Novovax step into Phase 3 trials

By Rahul Vaimal, Associate Editor
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In the United Kingdom, the US based biotech company, Novavax has begun the phase 3 trial for its experimental coronavirus vaccine.

It is the eleventh candidate for the COVID-19 vaccine to enter the Phase 3 stage globally.

The UK is currently witnessing a fresh wave of coronavirus infections that could provide good conditions for the trial. The vaccine candidate from Novovax is the fifth to join late-stage research supported by Operation Warp Speed of the Trump administration. The other vaccines are Johnson & Johnson, Moderna, Pfizer and AstraZeneca.

Johnson & Johnson began its Phase 3 trials in the US recently.

Over the next four to six weeks, the company plans to enroll 10,000 participants aged between 18 to 84, with 25 percent over 65 years and to target the groups most affected by COVID-19, including racial and ethnic minorities.

After a certain number of people in the UK trial get COVID-19 with symptoms, researchers can assess the efficacy of the vaccine, Dr. Gregory Glenn, president of research and development, said, noting the recent rise in cases means that the number will be reached earlier than if transmission rates were lower.

If the findings are positive, the study could lead to government approval of the use of Novavax in the United Kingdom and other countries, he said. But he did not name the countries.

In August, the UK government agreed to buy 60 million doses of the Novavax vaccine and to collaborate on a phase 3 study with the company.

Novavax, which has not yet brought a vaccine to the market, has secured $1.6 billion from the US federal government to finance its experimental coronavirus vaccine for development and mass production.

The company claims to have received $2 billion in funding for its global coronavirus vaccine program, including the Coalition for Epidemic Preparedness Innovation’s support of up to $388 million.

Glenn says the company also plans for a Phase 3 trial in the US with up to 30,000 participants and is expected to start in October. Further, it is undertaking a mid-stage vaccine trial in South Africa.

If the vaccine proves to be effective, Novavax has stated that it currently has the capacity to deliver 2 billion doses by mid-2021.

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