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The Public Ministry of the Federal Court of Accounts (TCU) asked the court this Friday for the “immediate suspension” of the contract signed the previous day by the Ministry of Health with Precis Medicamentos, manufacturer of the Indian immunizer Covaxin in Brazil, which provides for the purchase of 20 million doses of the Covid-19 vaccine between March and May.
Representing TCU, TCU Deputy Attorney General Lucas Furtado contested the fact that, even without authorization from Anvisa to conduct phase 3 clinical studies in Brazil, the government signed a R $ 1,614 million contract for the purchase of a vaccine that do not have proven efficacy for application in the country. MP with TCU is a specific career within the court itself.
Furtado said he has warned on previous occasions that the federal government and the ministry have “turned their backs on the technical recommendations of the scientific community and respected international institutions based on judicious studies.”
“The acquisition of unproven vaccines further delays the vaccination of Brazilians and puts the lives of millions at risk, as we face the worst phase of the disease, with the record of daily deaths recently reached. It should be noted that, at the moment, we have vaccine options! ”, he said.
“To the detriment of the acquisition of immunizers that do not have scientific evidence, the correct thing is to apply public resources efficiently and seeking effectiveness in the protection of Brazilians,” he amended.
In a note, the Ministry of Health informs that “the acquisition of Covaxin will allow to further ensure and expand the vaccination strategy of Brazilians against covid-19. The application of vaccines, such as any immunizer incorporated into the National Plan for Operation of Vaccination against Covid-19 (PNO), is subject to the prior obtaining of registration or authorization for emergency use by Anvisa ”.
The federal government portfolio also indicates that “payment by the Ministry of Health to each vaccine provider is also subject to obtaining authorization from Anvisa to use the immunizer.”
Distrust in India
India itself has struggled to convince its healthcare and frontline professionals to take Covaxin, whose approval without end-stage efficacy data was controversial.
The country has the second highest number of Covid-19 infections in the world, after the United States, with cases emerging recently as mask use declines and states have reduced social distance measures. The country’s lack of confidence in the vaccine could prevent India from meeting its goal of vaccinating 300 million of the total 1.35 billion people by August.
India has already vaccinated more than 10.5 million healthcare workers and frontline workers since the start of its immunization campaign on January 16. But only 1.2 million, or about 11%, took Covaxin, the vaccine developed locally by Bharat Biotech, while the remaining 9.4 million used the AstraZeneca vaccine, according to the government’s Co-Win online platform used to track the vaccination campaign. .
Inspection
On another front, Anvisa said on Friday that it will inspect the facilities of the Bharat Biotech company in India starting next week. The five servers assigned to the mission are already traveling to India, where they are due to arrive on Friday night, Brasilia time.
The inspection request had been submitted on February 13 and Anvisa and the laboratory agreed at the time to carry out the inspection for the first days of March.
The objective of the inspection is to evaluate and issue the Certificate of Good Manufacturing Practices (CBPF), which is a mandatory document for the vaccine registration process and the verification missions of the production line of the products are carried out at the request of the companies interested in regularization. .
“To date, an application to conduct clinical studies or to authorize the emergency use of the Covaxin vaccine, produced by the Bharat Biotech company, has not been submitted to Anvisa,” the agency said.
In practice, according to a source involved in the negotiations, the ministry could even buy these vaccines, but it will not be able to administer them for the time being without the endorsement of Anvisa.
In Congress, legislative proposals are being processed to relax the requirements for immunizers approved outside of Brazil.
The government has said that it will expand the supply of Covid vaccines to the population, although, so far, only CoronaVac and AstraZeneca-Oxford immunizers are authorized for emergency use in priority groups.
Anvisa granted this week the registration of wide use of the vaccine against Covid-19 developed by the North American pharmaceutical company Pfizer with the German BioNTech, but the government has not yet concluded the negotiations for the acquisition of this immunizer.
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