Last week Brazil’s health regulator Agência Nacional de Vigilância Sanitária (Anvisa) finally gave its approval for importing Bharat Biotech’s developed Covaxin vaccine.Several regulatory bodies in South American countries have started expressing interest in the indigenous Covaxin vaccine for vaccinating their population.
According to reports, Buenos Aires Province Governor Axel Kicillof last Friday has announced that a provisional agreement to procure 10 million doses of the Indian-made Covaxin vaccine. The deal with Bharat Biotech has been signed by the local government and not the national government of Argentina.
The approval was based on the condition that the first shot must get its approval by the drug regulator ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), of Argentina.
Last week Brazil’s health regulator Agência Nacional de Vigilância Sanitária (Anvisa) finally gave its approval for importing Bharat Biotech’s developed Covaxin vaccine.
How did it all start?
What started with the Ambassador of Ecuador participating in the Indian Vaccine trials has now led to new Latin American nations approving and accepting Covaxin as a viable vaccine for the Covid- 19 Pandemic.
The Indian policy of Vaccine Maitryi which also comes under the broad category of Vaccine diplomacy has resulted in a majority of the nations of the world being supplied with Covid Vaccines. “This manner of crises diplomacy is not new to India and is certainly not limited to Vaccines. Before the vaccines, there were PPE kits, masks, and medical equipment, HCQ tablets that India was supplying either as aid or as a part of a commercial deal. As the vaccines began, India played a pro- active role in sending out vaccines to regions and countries that are suffering,” a foreign policy expert opined.
Two vaccines – one Indian and one being produced in India
The Covishield and Covaxin are more economical alternatives to those developed by big pharma countries and have proven to be just as effective. Along with the advantage of being inexpensive, Vaccine diplomacy also cements the relationship between India and the receiving countries even further. While Covishield gained greater acceptance in Latin America, Covaxin faced initial hesitance and reluctance as it has not yet received the WHO approval. However, as Covaxin is being administered in India with no visible after effects, the vaccine has gained greater acceptance in the LAC region as well.
Countries like Guyana, Mexico, and Paraguay have decided not to await the WHO approval and have shown their faith in Covaxin as they start to receive and administer the vaccine dose.
According to reports, the approval in Brazil has been granted only for a limited doses of the Covaxin. Initially, the South American nation Brazil can import around 4 million doses and distribute and use under controlled conditions.
The step will be, data analysis by Anivisa which will be used for monitoring the use of the indigenous Made in India vaccine, and based on results, it will be decided to import more doses of the vaccines which are developed in India.
As has been reported earlier this year Health Ministry of Brazil had placed an order for the import of 20 million doses of Covaxin, which was turned down by the regulatory body Anvisa in March.
Last month, the Health Ministry of Brazil again approached the agency for its approval for importing the Indian vaccine. End of May, according to reports, Bharat Biotech approached Anvisa seeking approval for two Good Manufacturing Practices (GMP) certifications for Covaxin’s production.
The Brazilian regulatory agency has given its approval based on special conditions which includes that all the consignments from India to Brazil should be manufactured after the adjustments of GMP of Bharat Biotech.
Expert View from Brazil
Sharing his views with Financial Express Online, Balaji C Subramaniam, experienced professional from the pharmaceutical industry in Brazil, “As on date vaccines from four different manufacturers are approved by ANVISA Brazil. These include: CORONAVAC ( from Sinopharm China ) received temporary authorisation; J&J ( from Janssen ) received temporary authorisation; AZD 1222 ( from Astra Zeneca ) received final approval; COMRNATY ( from Pfizer BioNtech ) received final approval; SPUTNIK V ( from Gamaleya Institute Russia ) authorized for exceptional importation with limited quantity and monitored use; and Covaxin ( from Bharat Biotech ) authorized for exceptional importation with limited quantity and monitored use.”
According to Mr Subramaniam, with a close affinity on regulatory and business development, “Coronavac and Covaxin are produced out of inactivated coronavirus with one difference between them, Covaxin has been developed using a new adjuvant Imidazoquinoline (IMDG) which is not used in any other vaccine approved commercially in the world.
J&J vaccines are produced out of Human adenovirus Ad26; Astra Zeneca vaccines are produced out of adenovirus from chimpanzee; Sputnik V produced out of Human adenovirus Ad5 and Ad26; Pfizer BioNtech is an mRNA vaccine. All vaccines except J&J vaccines have to be taken in two doses with an interval of 3-8 week.”
“The platform used in most of the developed vaccines or vaccines in development are either from an attenuated virus or from a vector virus which is a well-tested platform in any vaccine development,” he explains.
“While choosing the platform to develop a COVID vaccine has become relatively easy after nearly 18 months of first cases of COVID 19, the big challenge still remains in obtaining good immunogenicity results demonstrating quality, safety and efficacy.
In this context the quality of the clinical studies is the key point which only shall help in obtaining regulatory approvals without any restrictions.
Vaccines are biological products, hence apart from a good clinical study it is also equally important to have a good manufacturing practise in production of a vaccine along with duly validated reports of key steps involved in production and quality control of vaccines produced by any company.
What happens after getting regulatory approvals?
“After obtaining regulatory approvals the other biggest challenge remains for developing countries are in nationalizing the production of active ingredient of these vaccines to be more independent which has been the very critical part of manufacturing these COVID vaccines in large scale to accelerate immunization in their respective countries,” Mr Subramaniam concluded.
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