Health regulator signs off on emergency use of Covid-19 vaccines

Anvisa board members Alessandra Bastos and Antônio Barra Torres
Anvisa board members Alessandra Bastos and Antônio Barra Torres

As Brazil’s vaccine race heats up, the board of directors of the National Health Surveillance Agency (Anvisa) has decided to allow emergency approval for Covid-19 vaccines. However, the agency highlighted that this temporary authorization may be suspended at any time, “based on technical and scientific evidence.” Anvisa says it has yet to receive any formal request for emergency authorization.

As the federal government dithers on announcing its nationwide immunization plan — with Health Minister Eduardo Pazuello stressing that clearance from Anvisa “for any vaccine” would take up to 60 days — the regulator’s decision brings Brazil much closer to approving Covid-19 vaccines for use among the general population.

Meanwhile, the Supreme Court is set to trial a case next week that would allow state governors to purchase vaccines that have been signed off on by foreign regulatory agencies, a maneuver that is technically permitted by an anti-coronavirus law ratified in February.

Law 13.979/2020 says that authorities may adopt “exceptional and temporary authorization” to import any health materials, inputs, medicines, or equipment that are deemed crucial to the fight against the Covid-19 pandemic, and which have been authorized by foreigh regulatory agencies. Among the authorities mentioned by the rule are the U.S. Food and Drug Administration, the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and the National Medical Products Administration in China.

Government forced into action

The federal government has been put under pressure this week, after São Paulo Governor João Doria announced an immunization plan for his state, which forecasts vaccination beginning January 25. 

In response, Health Minister Eduardo Pazuello doubled down by saying the federal vaccination plan could begin as early as late December, providing the Pfizer vaccine obtains emergency authorization from Anvisa. Today, Mr. Pazuello changed his tune and declared that the government intends to vaccinate the entire Brazilian population in 2021.