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RIO – Five million doses of the Covaxin vaccine, developed by the Indian laboratory Bharat Biotech against Covid-19, will be sent to private clinics in Brazil after the conclusion of negotiations between the company, the Brazilian Association of Vaccine Clinics (ABCVAC ) and the importer needs drugs. The information was released on Wednesday by the daily Valor Econômico. The immunizer, whose phase 3 tests have not yet been completed, has yet to be examined by the National Health Surveillance Agency (Anvisa).
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Negotiations between ABCVAC, which brings together 200 associates and represents 70% of the sector in Brazil, and Bharat Biotech were revealed at the beginning of January and generated debate about the supply of vaccines by the private sector. A delegation from the organization even traveled to India to advance the dialogue with the laboratory.
The details of the negotiation were sent to the members of the association on the 23rd and the final deadline to settle imports is next Friday, according to the Valor report. To reserve the vaccines, it is necessary to pay 10% of the amount of the signed contract, and the contribution can be returned if the formula is not validated by Anvisa.
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The clinics will make the payment of the doses directly to Precis Medicamentos. The price of each unit will vary according to the lot requested. In addition to the initial 10% payment, clinics must pay 50% of the contract value when Anvisa releases the use and importation of Covaxin and the remaining 60% upon delivery of the product.
Each clinic can buy a minimum of 2,000 doses. The ceiling established, according to the newspaper, will be 400 thousand doses. The unit values start from US $ 32.71 (R $ 176) for institutions that buy more than 100,000 vaccines. The investment increases gradually as the acquisitions are reduced: US $ 34.33 (184.53) between 50,001 and 100 thousand doses, US $ 36 (R $ 193.51) for orders of 12,001 to 50 thousand, US $ 38 (R $ 204.26) for batches of 7,201 onwards at 12,000 doses and $ 40.78 (R $ 219.20) per unit for institutions that buy between 2,000 and 7,200.
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Anvisa Rules
Bharat Biotech plans to finalize phase 3 studies at the end of February. The company’s expectation, according to Valor, is that Covaxin will be available in the Brazilian private sector in April. At the moment, Brazil has two formulas with emergency use authorized by Anvisa: CoronaVac, developed by the Chinese laboratory Sinovac Biotech, and Covishield, designed by the British company AstraZeneca in association with the University of Oxford (United Kingdom).
However, according to Anvisa rules, the sale of immunizers to private clinics is prohibited during the emergency use regime. Another obstacle is the requirement to carry out clinical tests in the country, the reason for the refusal of the request for authorization of the Russian Sputnik V in Brazil in the last 16 by the regulator.
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Covaxin is among the immunizers considered by the federal government in the Operationalization Plan for Covid-19 Vaccination in Brazil. Also according to Valor, the Ministry of Health is working with the hypothesis of acquiring 50 million doses of the vaccine, but a formal agreement has not yet been signed.
The Indian vaccine, like CoronaVac, is based on inactivated virus technology. It was designed to be applied in two doses, like the immunizers Butantan and AstraZeneca. The contribution from private clinics would be enough to immunize 2.5 million Brazilians.
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Covaxin had its emergency use authorized in India, but the move, taken before the completion of phase 3, which is unusual, has not escaped controversy. India’s independent health surveillance association, All India Drug Action Network, said it was “shocked” by the way the process was carried out in a statement issued a month ago. According to the entity, the decision raised “important concerns derived from the lack of data on effectiveness.”
