Brazil approves Sinovac and AstraZeneca vaccines for emergency use

Brazil granted approval for the emergency use of  vaccines from AstraZeneca and Sinovac Biotech against Covid-19 on Sunday, allowing the country to kick-start deploying shots as coronavirus  infections surge in Latin America’s largest economy.

Health regulator Anvisa cleared the vaccines in a meeting on Sunday, 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 is 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 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 health ministry had said 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 and health-care workers are first in line.

Only shot

Though it’s one of the countries hit hardest by the pandemic, ranking third globally in cases and second only to the US 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.

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 immunising its 212-million people.

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. An aeroplane 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.

Talks with other pharmaceutical companies including Pfizer have dragged. Earlier in January, health minister Eduardo Pazuello harshly 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 about 11-million doses of the Sinovac shot, called CoronaVac, on the ground. The vaccine is being made in partnership with local research institute Butantan. AstraZeneca partnered with another local player, Fiocruz, to produce the shots in Brazil.

On Saturday, Anvisa 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, did not 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 under way before seeking emergency authorisation.

Live meeting

The Anvisa meeting was broadcast in social media, and some local TV channels also dedicated Sunday coverage to transmit the hours-long discussion in full.

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.

Freitas and other Anvisa officials added that social distancing measures continue to be key, especially while Brazil does not have enough shots to immunise a large share of the population.

Second wave

While he backtracked on some of his more extreme comments and allowed the government to purchase Sinovac’s shot, 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 US and Europe, the country has seen a resurgence of the virus in recent weeks. Brazil reported 61,567 additional cases of Covid-19 and 1,050 deaths on Saturday. The country has about 8.5-million confirmed infections and 209,296 deaths.

Bloomberg