FAQ: Novavax Found 90.4% Effective, When Do We Get It in India?
Novavax says its vaccine is 93% effective against COVID-19 variants of concern and variants of Interest.
Novavax’s COVID-19 vaccine has an overall effectiveness of 90.4 percent in preventing symptomatic infection, announced the company on Monday, 14 June.
According to a statement released by the US based biotech company, its COVID vaccine, NVX-CoV2373, also gives 93 percent protection against "predominantly circulating variants of concern and variants of interest."
In previous studies conducted in the UK, Novavax demonstrated efficacy of 89.3 percent. The US FDA, however, requires the submission of data from trials conducted at least partly in the US before granting authorisation.
With the encouraging data from the much larger study being conducted in the US and Mexico, Novavax hopes to accelerate its COVID vaccine rollout.
For us here in India, this is good news. Serum Institute in India is the Indian manufacturer of the vaccine, named Covovax here. Manufacturing for the vaccine is reportedly already on, but we will have to wait for approvals by drug regulators before it is made available.
Here's what we know:
What do we know about the latest clinical trials?
According to their statement, the large study included 29,960 participants across 119 sites in the US and Mexico.
The preliminary results of the phase 3 clinical trials found the vaccine to be a 100 percent effective in preventing moderate and severe illness, and 91 percent effective in protecting high risk people.
The vaccine has also been found to be safe and “offers a reassuring tolerability and safety profile.”
Is Novavax effective against COVID variants?
Earlier in the week, Novavax had announced that it's COVID vaccine is effective against the highly contagious Beta variant (originally found in South Africa) and the Alpha variant (found in the UK) reported Reuters.
The company's latest press statement reaffirms this, saying that the vaccine demonstrated a 93 percent effectiveness against variants of concern and variants of interest.
“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus.”Gregory M Glenn, MD, President of Research and Development, Novavax
When is the authorisation in the US expected?
Novavax has previously been tested in a smaller clinical trial setting in the UK and South Africa, on top of the much larger ongoing trials in the US and Mexico.
The vaccine, though, has not received authorisation in any country yet.
According to their statement, the company plans on applying for regulatory authorizations with the US Food and Drug Administration (FDA) in the third quarter of 2021.
Novavax has now announced that it plans on producing 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.
Will Novavax be available in India?
Yes, Novavax's COVID vaccine is being manufactured by Pune based Serum Institute of India, under the brand name of Covovax.
The clinical trials for Covovax in India was announced by head of Serum Institute, Adar Poonawala in March 2021.
The agreement between the two companies to give SII the licence to manufacture and supply the vaccine in low income countries through COVAX facility was first announced in August 2020.
When will Novavax Vaccines be available in India?
Serum Institute head, Adar Poonawala, had in January 2021, announced that they were expecting to start production of “upwards of 40-50 million doses per month” in April and launch the vaccine in India by June.
However, in March, Poonawala announced that they expected to roll out the first batch of vaccines in India was delayed to September. He had also blamed the delay on US export ban on certain products essential to produce the vaccine. The ban has since been lifted.
What type of vaccine is Novavax?
NVX-CoV2373 is an experimental recombinant nanoparticle protein-based COVID vaccine that uses adjuvants.
The vaccine is stable in regular refrigerator temperatures of 2 to 8 Degree Celsius, making it suitable for storage and transportation in developing countries.
(With inputs from Reuters.)
(This article was first published in FIT and has been republished here with permission.)
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