(Bloomberg) -- Brazil granted approval for the emergency use of AstraZeneca Plc and Sinovac Biotech Ltd vaccines against Covid-19, allowing the country to kick-start deploying shots as the virus roars back in Latin America’s largest economy.
Health regulator Anvisa cleared the vaccines in a Sunday meeting, citing the recent significant increase in the number of Covid-19 cases in Brazil and the lack of alternatives for treatment of the disease.
While government technicians said there’s still information needed on the shots, the benefits of vaccinations outweigh the risks, according to rapporteur Meiruze Freitas.
“We must continue monitoring the vaccines to capture adverse effects that were perhaps not seen in trials,” she said.
Minutes after Anvisa finished its meeting, Sao Paulo began vaccinations, making Monica Calazans, a 54-year-old Black nurse, the first Brazilian to get a shot against Covid-19. Governor Joao Doria stood by her side with a shirt that read: Brazil’s vaccine. The state will start vaccinating health-care workers on Monday -- the first and second doses will be given 21 days apart.
Health Minister Eduardo Pazuello, who held a press conference in Rio de Janeiro, said the federal government wouldn’t do “a photo op” vaccination. After a “symbolic delivery” of shots to states on Monday, the national vaccination campaign will begin on Wednesday morning, he said, adding that distribution will be adjusted so that locations at higher risk receive more doses.
Previously, the ministry estimated it would take between three to five days for the shots to arrive in all states, and vaccination would start simultaneously across the country. The elderly, especially those in assisted-living facilities, Brazil’s indigenous population and health-care workers are first in line.
Only Shot
Although it’s one of the countries hit hardest by the pandemic, ranking third globally in cases and second only to the U.S. in number of deaths, Brazil has been late in vaccinating its 212 million citizens. Much like in the first phase of the pandemic, national vaccination plans have been marred by contradicting measures and political infighting. At competing press conferences on Sunday, Doria and Pazuello traded barbs on vaccination plans and who footed the bill for Sinovac’s vaccine in the country.
Sinovac’s shot, bashed publicly by President Jair Bolsonaro “because of its origin” in China, has become the sole option available for the country to start immunizing. The only other vaccine the government has purchased, AstraZeneca’s, has yet to arrive in Brazil.
Fiocruz, which will produce the shot locally, had forecast it would have doses ready just in February and a last minute push to get ready-made vaccines from India, announced by the health ministry last week, failed. A plane expected to fetch 2 million doses in Mumbai was diverted to deploy oxygen to the Northern city of Manaus instead, while the flight to India remains on hold.
On Sunday, Pazuello said the situation with India would be resolved in the next few days and that the shots should arrive next week.
Talks with other pharmaceutical companies including Pfizer Inc. have dragged. Earlier this month, Pazuello dismissed criticism that Brazil was falling behind in the vaccination race, saying the government had secured 354 million doses. At the time, he also said there weren’t enough shots available on the open market -- conceding, in effect, that Brazil had failed to seek them early -- and so the country would have to make its own.
Sao Paulo already has some 11 million doses of the Sinovac shot, dubbed CoronaVac, on the ground. Of those, 6 million are ready to be distributed nationally by the federal government. Sao Paulo, the country’s most populous state, will hand over about 4.6 million doses and keep 1.4 million to begin vaccinating. Doria said he’ll also send 50,000 doses to Amazonas, which is seeing a massive surge of new cases.
The shot is being made in partnership with local research institute Butantan. AstraZeneca partnered with another local player, Fiocruz, to produce the shots in Brazil. Both will have to file new requests for shots made domestically.
Emergency use
The Anvisa meeting was broadcast on social media, and some local TV channels also dedicated Sunday coverage to transmit the multi-hour discussion in full. All five directors approved the requests.
The rapporteur conditioned the approval of Sinovac’s vaccine to the signature of a term of commitment amid still missing data including on how long the shot offers protection -- a request not made of AstraZeneca’s vaccine. Butantan has until Feb. 28 to provide more information on the immunity generated by the vaccine.
Freitas and other Anvisa officials added that social distancing measures continue to be key, especially while Brazil lacks enough shots to immunize a large share of the population.
On Saturday, Anvisa had returned documents filed as part of an emergency use request for the Russian vaccine Sputnik V. Pharmaceutical company Uniao Quimica, which plans to produce the shot locally, didn’t comply with the minimum requirements for submission and analysis, the regulator said in a statement.
“It is not enough to file a request for Phase 3 clinical studies,” Anvisa said, adding the trials must be underway before seeking emergency authorization.
Second Wave
While he backtracked on some of his more extreme comments and allowed the government to purchase CoronaVac, Bolsonaro has repeatedly said he doesn’t plan to get vaccinated himself, and joked about “becoming an alligator” as a potential side effect of the Pfizer shot.
On Friday, Twitter marked one of Bolsonaro’s posts on early treatment of the disease as containing “misinformation potentially harmful regarding Covid-19.”
Like the U.S. and Europe, the country has seen a resurgence of the virus in recent weeks. Brazil reported 33,040 additional cases of Covid-19 and 551 deaths on Sunday. The country has about 8.5 million confirmed infections and 209,847 deaths.
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