With India now pandemic epicenter, Brazil seeks autonomy to produce vaccines

RIO DE JANEIRO, BRAZIL – With the global pandemic epicenter displaced to India, Brazil is now confronting the possibility of further delays in the delivery of doses from that country.

On Saturday, May 1st, India for the first time passed the 400,000 daily Covid-19 cases mark. A cumulative total of 211,853 deaths have been registered.

World Health Organization (WHO) director-general Thedros Adhanom said on Friday, April 30th, that the crisis Brazil is facing is complex due to the number of coronavirus cases and deaths, but he recognized that India is the focus of attention. Given the severe situation in India, the Brazilian government intends to prevent a shortage of supplies and vaccines by focusing efforts on domestic production.

In January, India sent Brazil 2 million doses. The quantity exported doubled in the following month. However, following new guidelines, the delivery of 8 million doses that would be sent to Brazil from India by the Serum Institute, the world’s largest producer of immunizers, has been deferred to the third quarter 2021.

A Foreign Ministry source considered that the date set by the Ministry of Health is conservative, but said that it may still be changed. With the worsening of the pandemic, India is not in a position to fulfill contracts at this time. According to the source, the vaccine batch from India is not part of the main strategy adopted by the Brazilian government and negotiations with other countries may undergo changes.

Given India’s critical situation, the negotiation of another vaccine from Bharat Biotech has cooled down. The Ministry of Health expects the delivery of 20 million vaccine doses, but has not specified a date. The Brazilian Health Regulatory Agency (ANVISA) in late March rejected the exceptional import of the vaccines, after assessing data related to the inspection of the immunizer’s manufacturing practices, which confirmed the lack of a technical report on the vaccine’s evaluation. Through a note, the Brazilian agency said it has not yet received a new certification request.

Bharat Biotech said in a statement that “the additional testing requirements detailed by ANVISA are complementary in nature and have no impact on the Covaxin’s safety, quality and efficacy. However, these additional requirements will be fully met and their deadlines have been submitted and accepted by the agency.”

A source linked to the Foreign Ministry said that even if these hurdles are resolved, the vaccine may take a while to reach Brazil, and even if its use is approved here, they will want to administer it domestically there.

Therefore, the main challenge for Brazil is to manufacture immunizers autonomously, with no need to import components or finished products. The two main vaccines with which Brazil is currently working – AstraZeneca and Sinovac – rely on the import of the active pharmaceutical ingredient (API) from China.

In mid-April, a delay in the delivery of APIs led to a halt in the production of the Coronavac vaccine. On Wednesday, April 28th, the Butantan Institute confirmed that it would deliver less than the 46 million doses expected by the Ministry of Health until the end of the month. One of the reasons for the delay was the exporting country’s decision to bolster its internal vaccination campaign. The São Paulo state government expects to be able to produce the Coronavac, with domestic API, as of December. Large scale production would occur in 2022.

In the case of the AstraZeneca/Oxford vaccine, Fiocruz said in a statement that “only after obtaining ANVISA’s certification of the facilities’ technical-operational conditions (CTO), will Fiocruz be able to start production, which should occur in May, with expected delivery of the first vaccines with domestic API to the PNI (National Immunization Program) in September.

On Friday, April 30th, ANVISA approved production of the API for the Covid-19 vaccine. According to a note published by the agency, “after testing, Fiocruz should request the inclusion of the raw material in the registry or submit a request for emergency use.”

Alternatives

Despite its focus on domestic production, Brazil is looking for alternatives to acquire vaccines from other countries. Brazilian ambassadors have been meeting regularly with U.S. authorities to negotiate a batch of 60 million doses of vaccines from AstraZeneca, which should be negotiated with countries in need. India would be the priority.

The first batch to be distributed should amount to 10 million doses, but the vaccine produced by AstraZeneca has not yet been approved by the FDA, the U.S. health regulatory agency. According to a U.S. government source, immunizers may only be shared after undergoing a quality control process. This is expected to be completed within the next two months.

Brazil’s Foreign Ministry officials said that the measure adopted by the United States sounded to some as politically motivated. The goal would be to show that the Americans are focusing more on helping other countries. However, the announcement may have been hasty, as information about the negotiation is still lacking, such as whether the vaccines will be sold or donated. A meeting has been held with White House immunologist and consultant Anthony Fauci, and there will soon be a meeting with U.S. Secretary of State Anthony Blincken to address the issue.

Brazil’s Foreign Ministry, the Embassies of India and the United States, and the Serum Institute failed to reply to a request for comments. The Ministry of Health reported that the Ministry of Foreign Affairs is the one responsible for dealing with international issues.

Source: CNN Brasil