Work at a Butantan factory delays national production of Coronavac

The work on the new vaccine factory at the Butantan Institute is finally completed. The initial construction forecast for the Multipurpose Center for Vaccine Production (CMPV) was the end of September 2021, but there was a delay in completion, and the work was only completed at the end of 2021.

Despite the completion of the building, national production of the Coronavac vaccine — and seven other vaccines, including rabies, HPV and hepatitis — should not take off anytime soon. The new center, built in a three-story building with 7,885 square meters, is still awaiting the arrival of the equipment to produce the immunizing agents.

For the civil works, the Butantan Institute received funding from 35 companies that made donations through Comunitas, a civil organization responsible for raising private funds for construction in partnership with the state government, totaling R$ 189 million.

According to the institute, at the moment and in the coming months, equipment and machinery will be installed, most of which are imported, which also reflects the delay.

The next step is automation and then certification by Organs competent bodies.

The physical structure of the place already existed — it is located in the space where the institute’s blood products factory should have been, which never went ahead. It had to be remodeled and adapted for vaccine production.

For this, it is necessary to build level 3 biosafety laboratories, where infectious biological material, in the case of viruses and bacteria, is manipulated.

In addition to the specificities required in this case, the large-scale production of immunizers undergoes strict quality control. In the country, Anvisa (National Health Surveillance Agency) makes visits to the factory and gives the approval for production, the so-called certificate of Good Manufacturing Practices (GMP). This ensures that different batches of vaccine have the same quality and safety profile.

As this step depends on the start of production of pilot batches, it is normal to have delays. For specialists in the production of vaccines, it is unrealistic to promise precise deadlines in cases like this.

People who are well versed in the vaccine manufacturing process at the institute spoke to the leaf, on condition of anonymity, to explain some of the mistakes that can happen when building a factory. One of the examples is the so-called laboratory virus escape. Another would be cross-contamination by other pathogens and microorganisms in vaccine production.

In addition, it is necessary to have the original virus to be cultivated in bioreactors, in the case of Coronavac, or in another type of material — some vaccines for Covid are grown, for example, in cells called Vero, which are a cell line obtained from the green monkey kidney in the 1960s.

At the moment, the institute has 15 million doses of the immunizer stopped, produced with Chinese API and bottled in the factory in São Paulo. The doses, which were refused by the Ministry of Health for the vaccination campaign against Covid-19, continue without a certain destination.

A possible way of using these vaccines, according to the director of the institute, Dimas Covas, would be for the immunization of children, if Anvisa approves Coronavac among those aged 3 to 17 years. So far, the immunizer has received authorization for emergency use in people over 18 years of age.

If there is authorization, the national production of doses of the immunizer is the institute’s great bet in 2022. One year after the beginning of vaccination against Covid in the country, when the inactivated virus vaccine was the main protagonist in the first months of the campaign, the use of the immunizer in the country has plummeted to less than 10%, as shown by a report by the leaf.

The application of Coronavac to children can expand the national projection of the governor of São Paulo, João Doria (PSDB), pre-candidate for the Presidency.

The use of Coronavac in the vaccination campaign had its ups and downs, with several disputes with the federal government, which first rejected the vaccine, then signed an agreement that was disallowed by Bolsonaro, in an episode that became known as the vaccine war.

The Ministry of Health only announced the inclusion of the Chinese immunizer in the national plan on December 15, 2020, about six months after announcing the agreement with Oxford/AstraZeneca and Fiocruz.

The health ministry signed an agreement to purchase 100 million doses of Coronavac. By the end of November, 82.4 million doses had been administered in Brazil to the population over 18 years of age.

This week, Anvisa must decide whether to release the use of Coronavac in children.