Covaxin: Itamarti warns health experts question ‘rapid’ approval in India Waldo Cruz Blog

News date: 25 June 2021Source: https://www.sproutwired.com/covaxin-itamarti-warns-health-experts-question-rapid-approval-in-india-waldo-cruz-blog/

The alert was issued on 5 January. In the report, Brazilian diplomats report that the Indian press celebrated emergency approval of the Oxford/AstraZeneca and Covaxin vaccines, “but without approval for both the final efficacy data for the vaccines and the perceived opaque process of deliberation by official bodies.” raised doubts about”.

 

At the time of approval, the report said, India’s health regulator approved Covaxin on an emergency basis even before the third phase of the trial, which is considered essential for the safety of the immunizing agent.

 

The diplomat responsible for the document also pointed out that a Bharat Biotech interlocutor acknowledged that the recruitment of volunteers for the third phase was “in progress”.

 

This month alone, Bharat Biotech reported that it has completed Phase III and said that the effectiveness has reached 77.8%. The laboratory has not yet released clinical studies of this stage of vaccination agent development.

 

On 25 February, i.e. before the completion of Phase III and even before it received emergency approval by the health regulatory agency in India, the Brazilian government agreed to supply 20 million doses of Covaxin at a cost of $15 to Nesacid and India. Signed a contract with Biotech. per unit.

 

The agreement provided that the purchase was subject to the approval of Anvisa. On March 29 this year, the Brazilian agency rejected a request for “good practice” by the Bharat Biotech Laboratory. On the last day of the month, Anvisa did not authorize the import of Covaxin. Only on May 14 did the agency release the vaccine, but with restrictions.

 

According to the health server who will testify this Friday, he refused to sign an import license for about 300,000 doses of the immunizing agent, which would allow an advance payment of US$45 million for the purchase of Covaxin. The payment will be made to a Singapore-based company called Madison Biotech, the contract signed with Nesidaid on behalf of Bharat Biotech.

 

In the meeting with the president, Bolsonaro would have told the server that he would condemn the pressures to the federal police. However, the government accused the import chief of tampering with documents and announced that he would be investigated along with his brother, federal deputy Luis Claudio Miranda (DEM-DF).

 

Kovid’s CPI leadership is expected to clarify who is right. The government says the document has been tampered with, and that one that would allow advance payments from Covaxin has been filed in the health ministry’s system.