New data shows coronavirus vaccine is safe and promotes an immune response

New data shows coronavirus vaccine is safe and promotes an immune response

Novavax Inc whose Covid-19 vaccine candidate showed promising results in the initial clinical trials has signed an exclusive supply and license agreement with India's Serum Institute for the production of the Covid-19 vaccine in India.

The company said it could start a large pivotal Phase III trial as soon as late September, and on a conference call added that it could produce one billion to two billion doses of the vaccine in 2021.

"That's good. That's really encouraging", Novavax president Dr. Gregory Glenn said.

After the first dose, all subjects who got the vaccine developed antibodies that block SARS-CoV-2's "spike protein", which it uses to latch on to human cells.

The vaccine candidate produced anti-spike IgG antibodies in all subjects after a single 5 µg dose, and numerous subjects also developed wild-type neutralizing antibody responses.

On Tuesday, the company had said that the volunteers who had been administered the vaccine developed twice the amount of antibodies in comparison to the patients who had recovered from the disease.

The Phase I trial, which began in late May, tested the vaccine in 106 participants between ages 18 and 59 while 25 people were given a placebo at two sites in Australia.

Effective vaccines and treatments are considered essential to halting a pandemic that has claimed more than 695,000 lives worldwide.

A month after scoring $1.6 billion from the US government, Novavax is posting the first human data from its COVID-19 vaccine. It is using the Operation Warp Speed funding to finish late-stage clinical development of its COVID-19 vaccine, including a phase 3 study that would enroll up to 30,000 patients. What's more, the lower dose fared "comparably" to the higher dose.

The vaccine also induced a response from T-cells, a type of immune cell, according to an analysis of 16 randomly selected volunteers, the report said.

On the safety side, the most common side effects were headache, fatigue and muscle pain, but the majority were mild and lasted, on average, less than two days. "When you are talking about vaccinating the entire world, safety is nearly more important than efficacy", said Brad Loncar, chief executive of Loncar Investments, an investment fund specializing in biotechnology companies.



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