Anvisa issues unprecedented Emergency Use Authorizations for two Covid-19 vaccines

​On January 17, 2021 the Board of Directors (Dicol) of the Brazilian Health Regulatory Agency (Anvisa) unanimously approved Emergency Use Authorizations (EUAs) for two vaccines – one for CoronaVac, developed by the pharmaceutical company Sinovac in partnership with the Butantan Institute, and another for Covishield, produced by the Serum Institute of India in partnership with AstraZeneca/University of Oxford and Fiocruz.

Established in December 2020, Anvisa’s procedure for analysis of EUA applications considers an assessment of the risks and benefits of each product and is based on available evidence related to aspects of effectiveness, safety, biotechnology, good manufacturing practices and pharmacovigilance. It is important to emphasize that the EUAs do not replace the Marketing Authorization (MA), usually granted by Anvisa.

See the main differences between the two mechanisms below:

Besides the scientific evidence presented by the developers of each vaccine, Dicol’s decision has also considered the absence of therapeutic alternatives available for the treatment of patients diagnosed with Covid-19, as well as the ongoing national and international public health emergency situation presented by it.

Applicant companies must commit to continuing their clinical studies and generating real-world data, including in regard to monitoring the vaccines’ safety and their long-term effects, so as to eventually allow Anvisa to reclassify these vaccines under the MA definitively.

New stage in the fight against the pandemic

With the granting of these two EUAs, Brazil enters a new stage in the fight against the Covid-19 pandemic, commencing the distribution of available vaccine doses. This must be done in accordance with the National Plan for the Operationalization of Vaccination against Covid-19 which is drafted, updated and coordinated by the Ministry of Health, as well as with the requirements established in the Provisional Measure No. 1,026/2021 (PM No. 1,026/2021) published on January 7, 2021.

Main topics of the PM No. 1,026/2021 include:

• Public and private health services must record daily and individualized data regarding the application of Covid-19 vaccines as well as any possible adverse events, in an information system provided by the Ministry of Health.
• The health professional responsible for administering the vaccine covered by an EUA granted by Anvisa must inform the patient that the product is yet to be registered with Anvisa, having only been granted the EUA, along with informing of the potential benefits and risks of the product.

• Legal private entities must share essential data for both the identification of infected persons in outpatient or hospital treatment, and/or those suspected to have been infected by Covid-19 upon Anvisa’s request – subject to the pre-existing regulations in force for the protection of personal data.
• The validity of medical or dental prescriptions for prescription drugs and their ongoing use (except drugs subject to special control) will be extended until the end of the National Plan for Vaccine Operationalization.

• Implementation of customized public law rules for the purchase of vaccines, supplies, goods and logistics services, information and communication technology, media and advertising, and training for vaccination against Covid-19.

PM No. 1,026/2021 is valid for a 60-day period, extendable for the same duration. Although the legal effects of a provisional measure are immediate, the wording of its text depends on the considerations of the National Congress (both the House of Representatives and Senate) to become a regular law. PM No. 1,026/2021 becomes an urgent priority if it is not reviewed within 45 days of its publication, moving to the front of the line of the legislative deliberations in the House where it is being processed.

Authorizations for the importation and distribution of unregistered vaccines

Similar to what has already been established by Federal Law No. 13,979/2020, PM No. 1,026/2021 also stipulates the possibility for Anvisa to grant exceptional and temporary authorization for the importing and distribution of Covid-19 vaccines, materials, drugs, medical devices and supplies that are not registered at Anvisa, and are considered essential for fighting the pandemic.

In addition to the American, European, Chinese and Japanese health authorities, PM No. 1,026/2021 includes the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) on the list of agencies that the product must be registered with.

Although the PM fails to mention a deadline for Anvisa’s analysis, the following scenario is presented:

• Anvisa would be subject to a 72-hour deadline for authorization of the import and distribution of products registered with the FDA, EMA, PMDA and NMPA, as set forth in Law No. 13,979/2020, which remains in force by virtue of the decision rendered by Supreme Federal Court (STF) Justice Ricardo Lewandowski, in the records of ADI No. 6625 MC/DF;
• For granting authorization to import and distribute products registered with the MHRA, applicable deadlines depend on each type of product, as set by Anvisa.

National Plan of Vaccination Operationalization

As provided for in the Brazilian Federal Constitution, the Union, states and municipalities are commonly competent to legislate on health protection and defense (article 24, XII), as well as to take care of health and public assistance (article 23, II).

Based on this constitutional panorama, there has been frequent judicialization of issues involving federal entities during the pandemic. Although this is a recent turn of events, it is already possible to identify judicial controversies related to article 13 of PM No. 1,026/2021.

For example, as stated in the records of the ADI nº 6625 MC/DF (currently before the STF), the Sustainability Network Party has requested  a jurisdictional declaration that the National Plan of Vaccination Operation against Covid-19 “not prevent States, the Federal District and Municipalities from commencing vaccinations through state and municipality-led vaccination plans.”

Despite the aforementioned addition not having yet been judged, it should be noted that under ADPF No. 770 MC/DF, filed by the Federal Council of the Brazilian Bar Association, the STF has already taken the position that if the National Plan for the Operationalization of Vaccination against Covid-19 is either not complied with or does not provide timely and sufficient immunological coverage against the disease, the States, Federal District and Municipalities are authorized to distribute available pre-approved vaccines to their respective populations.

For more information on Covid-19 regulations, please contact Mattos Filho’s Life Sciences and Healthcare specialists.