Covaxin, Covishield updates: Bharat Biotech has not yet applied for approval by Brazil’s health regulator Anvisa for its Covaxin vaccine, and the agency said it would have to undergo Phase III human trials in the country.
Covaxin, Covishield updates: In a major boost to the authenticity of Covid-19 vaccine Covaxin, Brazil’s private clinics have inked a preliminary deal for the Coronavirus vaccine developed by Bharat Biotech. Along with this, the Latin American country has also made a diplomatic push to secure the Serum Institute of India’s Covidshield, a version of Oxford-Astrazeneca’s vaccine against Coronavirus. This has come even as apprehensions have been raised over the efficacy of Covaxin due to “a lack of public results from late-stage trials”, as per a Reuter report.
As Brazil’s government and private sector scrambled to secure doses of Coronavirus vaccines, the urgency underscored how South America’s largest nation, once an example of mass immunization success in the developing world, has fallen behind peers in the race to inoculate against the highly contagious Covid-19, the Reuters report said.
Covaxin will be the first vaccine in Brazil’s private market
An association of private Brazilian clinics has announced its ambitious plans to procure 5 million doses of Covaxin. However, Bharat Biotech has not yet applied for approval by Brazil’s health regulator Anvisa for its Covaxin vaccine, and the agency said it would have to undergo Phase III human trials in the country.
Head of the Brazilian Association of Vaccine Clinics (ABCVAC) Geraldo Barbosa is leading a delegation to India. He has said a memorandum of understanding has already been signed with Bharat Biotech. “This should be the first vaccine available on the private market in Brazil,” he said, adding that the Covaxin doses should arrive in Brazil in mid-March, to be sold by private clinics after regulators there approve the vaccine.
Anvisa said in a statement on Sunday that Covaxin does not fit the continuous data submission process for vaccine registration and the vaccine would have to undergo late phase clinical trials in Brazil.
Why is Brazil taking a diplomatic route for the Covishield vaccine?
Brazil’s death toll due to Covid-19 is only second to the US and the government in that country has been facing criticism for its slow response. Brazil is also playing catch up to neighboring Chile and Argentina where vaccine inoculations have been started. However, Brazil’s Fiocruz Institute’s plans to import AstraZeneca’s vaccine in bulk, filling and finishing doses locally would only have 1 million doses ready by the second week of February, the head of the government-funded biomedical center has revealed.
In addition to these issues, the Chief Executive of the Serum Institute of India Adar Poonawalla had already said that he expected the Government of India to restrict the export of COVID-19 vaccines. This has raised concerns in Brazil as health regulator Anvisa had granted approval on New Year’s Eve to import 2 million doses of the AstraZeneca vaccine from India.
Brazil’s government is optimistic that it will be able to import the vaccines from India and any hurdles will be resolved diplomatically, a Brazilian official with knowledge of the matter told Reuters. Two people familiar with the matter said diplomats were working to confirm the shipment would not be affected by any export ban. Fiocruz confirmed that Brazil’s Foreign Ministry was leading the talks, the Reuters report says.