Bharat Biotech’s Covaxin does not meet the standard: Brazil; Why is Covaxin struggling to find International Takers?

Bharat Biotech International Limited had confirmed in February that the company had signed a deal with Brazil for the delivery of 20 million doses of the Covaxin vaccine.

The company had issued a statement in this context: “The company is delighted to partner with Brazil in its battle against Covid -19 and aid its immunization program against the virus. It has signed an agreement for the delivery of COVAXIN during Q2 (April – June) and Q3 (July – September) of 2021.

However, in a twist, the Brazilian health regulator ANVISA has said that the Covid -19 vaccine Covaxin, developed by Bharat Biotech, doesn’t meet its manufacturing standards.
Just last month, Brazil had entered into an agreement with Bharat biotech and agreed to buy the vaccine, and Bharat Biotech applied for the vaccine’s emergency use on march 8.

In January, India had dispatched two million doses, and Brazil President Jair Bolsonaro had thanked Prime Minister Narendra Modi by saying “dhanyavaad” for supplying the “sanjeevni booti” against the virus to Brazil.
Brazil is one of the worst-hit countries and currently accounts for a quarter of Covid -19 daily deaths worldwide, and is more than any other country; its vaccination efforts have not panned out well and have been hampered by lack of shots.

President Jair Bolsonaro signed an executive order to disburse 5.3 billion reais ($918.08 million) in new loans to fight the Covid – 19 pandemic; however, Bolsonaro has come under heavy criticism for his handling of the pandemic.

Bharat Biotech, and its Brazilian partner Precisa Medicamentos, have issued a statement that they would appeal the decisions and would present evidence that it is complying with all requirements.

India’s grand Covaxin gesture
India’s decision to supply Covaxin to several countries as a goodwill gesture has garnered international headlines.
In its grand gesture, India decided to export 8.1 lakh doses of Covaxin to Oman, Mongolia, Myanmar, Bahrain, Mauritius, Maldives, and the Philippines.
Meanwhile, Serum Institute was to supply a few doses to Seychelles, Afganistan, Bangladesh, Nepal, and Bhutan.

However, Both Bharath Biotech and Serum Institute of India had also signed respective deals with foreign countries to supply vaccines.
The move on India’s part was applauded by the rest of the world, especially the countries mentioned above who were in dire need of vaccines.

Today, however, the scene seems to turn, as many companies have come out with their version of the vaccine, the efficacy of several of these is under the scanner, and many have halted the use of some as a result of side effects resulting from the vaccination.

Covaxin not finding International Takers
India was steadily on the path of making a mark in the world with vaccine diplomacy amid the covid crises, but media reports suggested in February that they were very few international takers for homemade Covaxin.

The numbers are somewhat surprising; of the 8.1 lakh doses of Bharath Biotech’s Covaxin that India promised to grant in aid to seven countries, Myanmar only procured 2 lakh doses.
According to sources, of the 64.7 lakh Covid vaccine doses that India has sent out, only 2 lakh were Covaxin doses; the rest of the doses are of Serum Institute’s Covishield.

One of the significant hurdles coming in the way of Covaxin is the fact that Covaxin is yet to complete its phase III trials; it had only started its phase III trials in November 2020 and had enrolled 25,800 volunteers for the same across the country.
However, up until now, 25,000 volunteers have received both doses; hence the next step regarding the efficacy of the vaccine is yet to be available, and for the same, the developers of the vaccine would require at least 43 Covid positive cases among the volunteers.

Thus, the Indian government soon found fewer takers for Covaxin, thus prompting the Indian government to say that countries are free to carry out bridging studies of the vaccine in case their regulator wishes them to do so.
Meanwhile, accepting this fact that since the Phase III trials were still on and the data regarding the efficacy of the vaccine was still to be published, the developers of the vaccine have acknowledged that publishing data regarding the effectiveness of the vaccine will take time.

Bharat Biotech has taken assurance from the fact that as per data, it is seen that the vaccine is generating Covid neutralizing antibodies, and the data regarding safety and immunogenicity of the vaccine has been published in the Lancet — a development that was underscored by the Indian Council of Medical Research which has collaborated with BBIL for developing of the vaccine.

Incidentally, the Delhi’s premier RML Hospital’s resident doctors had also sent a letter to the hospital superintendent saying that they do not want to take Bharat Biotech’s Covaxin and would prefer the Covishield vaccine of Serum Institute of India since the former was yet in phase III clinical trial.

The fact that in India itself, they are a certain apprehension when it comes to Covaxin, then it does not come as a big surprise that Brazil has taken this stand and has issued a statement in this regard.