Brazil’s health regulator authorizes exceptional Sputnik V import by another 7 states

RIO DE JANEIRO, BRAZIL – A total of 592,000 vaccine doses will be imported by Rio Grande do Norte, Mato Grosso, Rondônia, Pará, Amapá, Paraíba and Goiás. Import authorization had already been granted to Bahia, Maranhão, Sergipe, Ceará, Pernambuco and Piauí.

The Brazilian Health Regulatory Agency (ANVISA) on Tuesday evening, June 15, authorized the exceptional import of the Sputnik V vaccine by 7 more Brazilian states: Rio Grande do Norte, Mato Grosso, Rondônia, Pará, Amapá, Paraíba and Goiás.

In all, another 592,000 doses may be imported, to be distributed as follows:

Rio Grande do Norte: 71,000
Mato Grosso: 71,000
Rondônia: 36,000
Pará: 174,000
Amapá: 17,000
Paraíba: 81,000
Goiás: 142,000

Authorization was granted subject to the same restrictions applied to 6 other states also granted exceptional import authorization early this month – Bahia, Maranhão, Sergipe, Ceará, Pernambuco, and Piauí. In all, these states were allowed to import 928,000 doses.

Some of the conditions established are as follows:

The vaccine should be administered only in healthy adults.
All imported batches may only be used after clearance by the National Institute for Quality Control in Health at Fiocruz.
ANVISA will receive periodic reports evaluating the vaccine’s risk-benefit.
The vaccine must be used under controlled conditions, with an efficacy study conducted, with the design agreed with ANVISA and executed according to good clinical practices.
ANVISA may, at any time, suspend import, distribution and use of imported vaccines.
People should be informed that the vaccine has not been “evaluated” by the agency for quality, efficacy and safety.

The vaccine may NOT be applied in the following cases:

People with hypersensitivity to any of the formula’s components
Pregnancy
Lactating
Under 18 or over 60 years of age
Women of childbearing age who wish to become pregnant within the next 12 months
Severe or uncontrolled illnesses and a history of anaphylaxis
People who have been administered another Covid-19 vaccine
People with fever
People with HIV, hepatitis B, or C
People who have been vaccinated within the previous 4 weeks
People who received immunoglobulins or blood products 3 months prior
People who have received immunosuppressive, cytotoxic, chemotherapy, or radiation treatments 36 months prior, have received biologic therapies including anti-cytokine antibodies and other antibodies.