New Delhi: The Brazilian health regulator Anvisa (short for the Portuguese Agência Nacional de Vigilância Sanitári), has denied a certificate for good manufacturing practices to Bharat Biotech, who it was inspecting as part of the process to procure its COVID-19 vaccine, Covaxin.
The announcement that Bharat Biotech’s vaccine does not meet its manufacturing standards was published in a note on the March 30 edition of the official gazette, Reuters has reported.
Covaxin is one of the two vaccines currently being administered in India. Brazil is the second-worst COVID-19-affected country in the world, in terms of deaths, after the US.
The Brazilian government signed a contract with Precis Medicamentos, Bharat Biotech’s representative in Brazil, to buy 20 million doses of the vaccine. Anvisa’s clearance is a necessary step for the country’s process of authorising this vaccine for emergency use.
“In principle, it is understood between both parties that supplies of Covaxin [are] to be prioritised for the public market, through a direct procurement by the government of Brazil. Supplies to the private market would be based upon receipt of market authorisation from ANVISA, the Brazilian regulatory authority,” Bharat Biotech had announced in a press release in January, 2021.
Bharat Biotech had applied for emergency use of the vaccine in Brazil on March 8. The delivery was supposed to have taken place between March and May, Brazilian website Universo Online has reported.
It is unclear as to whether Brazil’s plans for the procurement of Covaxin is delayed, entirely cancelled or – in the light of Bharat Biotech’s January note – partially cancelled.
UOL noted in Portuguese that the reasons why Covaxin fell short of manufacturing standards included its reported “failure to comply with several…rules and instructions on good production practices.” The problems relate to non-adherence to demands for documentation, methods of analysis, and integrity of containers. Methods used for “sterilising, disinfecting, removing or inactivating viruses” also came under the scanner, UOL reported.
Between March 1 and 5, a team of five inspectors reportedly analysed “all factory areas of the lines that produce biological active pharmaceutical ingredients and vaccines”.
Among COVID-19 vaccines which received the green-light from Anvisa are CoronaVac (produced by Sinovac Biotech), the Johnson & Johnson vaccine (by J&J’s pharma division Janssen-Cilag), the Pfizer-BioNTech vaccine and the AstraZeneca-Oxford University vaccine (marketed in India as ‘Covishield’), according to UOL.
Reuters has it that Anvisa certified four vaccine makers on March 30 itself, including three units belonging to the Johnson & Johnson group, and one which is part of Brazilian drugmaker União Química, which has an agreement to produce Russia’s Sputnik V shot locally.
Earlier in the month, The Wire Science had reported that Bharat Biotech had spoken of it being in the process of filing regulatory documents for Covaxin’s approval in more than 40 countries. The company had claimed that Brazil, France and the United Arab Emirates were among them. “Earlier, a committee of experts in Mexico recommended the approval of Covaxin,” the website Moneycontrol had also noted.
Covaxin’s arrival has been fraught with questions on ethical practice. The Wire Science has, across articles, closely tracked the various issues that has plagued the vaccine candidate, from its inception to its efficacy to its misleading advisory to questions about institutions chosen to conduct trials.