Brazilian institute to start production of vaccine CoronaVac

The Butantan Institute, a Brazilian biological research center, has started manufacturing CoronaVac, a vaccine against the novel coronavirus (COVID-19), still in its testing phase. Production will be conducted in partnership with Chinese pharmaceutical company Sinovac. According to São Paulo state Governor João Doria, production kicked off Wednesday (Dec. 9).

The vaccine will be produced in successive 24-hour shifts, seven days a week, the governor declared. The state government intends to reach full capacity—up to a million doses manufactured a day. Until October, the institute’s production unit worked from Monday to Friday with two shifts.

The planned capacity for vaccine packaging at Butantan is 600 thousand to a million a day. The first batch should include approximately 300 thousand doses. The São Paulo state government estimates that some 40 million doses of the vaccine will be produced by January.

Butantan’s factory occupies a productive area of 1,880 square meters and currently has 245 professionals. Another 120 employees will be hired to bolster the output, the government stated.

Vaccine

The São Paulo state government has forged a partnership with Chinese pharmaceutical company CoronaVac by means of the Butantan Institute. The agreement has started brought over doses of the vaccine. The deal also includes transfer of technology to Butantan.

Phase 1 and 2 studies on the vaccine, conducted in China, have demonstrated it is safe, i.e. it caused no severe collateral effects. Tests carried out with volunteers in Brazil confirmed its safety.

The vaccine, however, is still going through its third and last phase of testing, which should reveal whether it is efficient. These tests have been developed in Brazil since July this year, and, in order for its first results to be disclosed, a minimum of 61 voluntary participants had to be contaminated with the new coronavirus—as half of the volunteers were given a placebo, and the other half received the vaccine. In order to ascertain whether a vaccine works, most of the people infected with the virus must be among those who were administered the placebo.

The minimum number of volunteers contaminated in the tests was reached in November and allowed the assessment on vaccine efficiency to begin. The result was submitted to an independent international committee, and the state government expects the outcome to be unveiled to the public next week.

If the vaccine is indeed proved to be efficient, the state government of São Paulo will request approval for registration at the country’s national sanitary regulator Anvisa, which should then allow its use in Brazilian territory.

The São Paulo state government has received from Sinovac 120 thousand ready-for-use doses and a million doses to be packaged by the Butantan Institute. Under the terms signed late in September with Sinovac, Butantan will receive 46 million doses of CoronaVac, 6 million of which are to come already prepared for use.

Governor João Doria said that, of 11 states and 912 municipalities have shown interest in acquiring doses of the vaccine.