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SII's Covovax gets emergency use approval from WHO: Why it's being hailed as a milestone

TIMESOFINDIA.COM | Last updated on - Dec 19, 2021, 11:00 IST
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Here's everything we know about Covovax so far

On Friday, the World Health Organization (WHO) granted emergency use approval to Serum Institute's Covovax vaccine, making it the 9th COVID-19 vaccine to get WHO's approval.


In an official statement, the WHO said, “Today, the World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named Covovax, is produced by the Serum Institute of India under license from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries."


Celebrating another 'milestone', Adar Poonawalla hailed WHO's approval of the vaccine and tweeted, "Covovax is now WHO approved for emergency use, showing excellent safety and efficacy."


Read also: Explained: Why are fully vaccinated people with no travel history testing positive for Omicron

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Covovax is a two dose COVID-19 vaccine

Serum Institute of India's Covovax is a protein subunit of the vaccine developed under licence from American biotechnology company Novavax, and the Coalition for Epidemic Preparedness Innovations (CEPI). The collaboration was made official in 2020, wherein Novavax had given the Pune-based company SII the licence to manufacture and supply the vaccine to low- and middle-income countries including India.


Like other COVID-19 vaccines in India, it is a two dose shot that requires 2 to 8 °C refrigerated temperatures for stability.

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How does it work?

All COVID-19 vaccines primarily target the spike protein.


Covovax is a recombinant protein vaccine that uses spike proteins to infect and train the immune system to fight off infections. The vaccine is made by creating an engineered baculovirus containing modified SARS-CoV-2 spike genes. Then the virus carrying the spike gene is used to infect the moth cells. The cells then create spike proteins associated with the novel coronavirus. The spike proteins are harvested and purified, following which a certain dosage of these spike proteins are used as the vaccine.


Given that these spike proteins contain no live components of the virus, they are said to be safe and do not lead to actual infections. However, these work towards triggering an immune response, which in turn produce antibodies.


That said, vaccines are a mimicry of the virus, aimed to build a protective layer of antibodies against an actual virus.

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Amid new emerging variants, will it prove efficacious?

Amid emerging variants, coronavirus vaccines are nothing short of a blessing. Although fully vaccinated people are still prone to contracting the virus, growing evidence suggests that it can prevent severe infections, minimizing the risk of hospitalization and death.


As far as Covovax is concerned, clinical studies have shown an efficacy of 96.4% against mild to severe COVID-19 infection. Additionally, it also showed an efficacy of around 83.4% two weeks after the first dose.


The vaccine has also proved efficacious against some of the new emerging variants. While it showed an efficacy of around 86.3% against UK's Alpha variant of SARs-COV-2 virus, it only managed a 49% effectiveness against the Beta variant that was reported in South Africa.


In terms of the Delta variant, Novovax, the US brand name for Covovax, said that a third booster dose of its vaccine administered six months after the two dose regimen could provide 4.6-fold increase in the antibody count.


Now with Omicron variant wreaking havoc around the world, it is yet to be seen whether Covovax vaccine will prove effective against the new variant.

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'Much better than Covishield'

According to Anurag Agrawal, one of the directors of the government's genome sequencing monitoring agency INSACOG (Indian SARS-CoV-2 Genomics Consortium), Covovax “induces a strong immune response and has an excellent safety profile.”


When it comes to booster shots, he believes that Covovax has greater efficacy than Covishield.


“I do not think that the approved version, based on ancestral spike protein, will be directly very effective against Omicron since its efficacy against Beta was around 50 per cent (much better than AZ though). It is better than a third dose AstraZeneca/Covishield as a booster,” he said.


But he also states that more data is needed to confirm the efficacy of the Novovax vaccine against the new COVID variant Omicron.


Additionally, he believes that the WHO approval was good news for India and that the government should not waste time in rolling out Covovax as a vaccine booster.

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What does it mean for the kids?

Recently, Serum Institute of India (SII) CEO Adar Poonawalla announced the plans to launch Covovax jab for kids, in the next six months.


“We haven't seen a lot of severe disease in children. Fortunately, panic is not there for kids. However, we will be launching a vaccine for them in six months, hopefully down to the age of three,” he said.


“Our Covovax vaccine, which is under trial and has shown excellent data all the way down to the age group of three years, will be launched in six months,” he further said. This was before Covovax received emergency use approval by the WHO.


In addition to his statement on launching a vaccine, he also highlighted the importance of vaccinating kids. “Yes, I think you should take and get your children inoculated. There's no harm, these vaccines have been proven to be safe and efficacious. Just wait for the government's announcement, and then you can go ahead,” he stated.


As of now, people aged 18 and above are eligible to get vaccinated in the country. Currently, among the coronavirus vaccines given Emergency Use Authorisation (EUA) by the Drugs Controller General of India (DCGI), only one, which is the Ahmedabad-based Zydus Cadila's ZyCoV-D, has been given approval for everyone aged 12 and above.

Top Comment
bcc biaora
1623 days ago
it's time to authorize covovax for use in india and allow it for booster dose
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