MercoPress. South Atlantic News Agency

Anvisa still waiting for Pfizer's reply regarding their covid-19 vaccine

Anvisa gave Pfizer 120 days to submit information to decide whether the benefits of the vaccine outweigh the risks

Brazil's National Health Surveillance Agency (Anvisa) has requested some additional information from Wyeth/Pfizer regarding booster doses of their COVID-19 vaccine for children and adolescents and is still waiting for a reply, Agencia Brasil reported Friday.

The pharmaceutical company had applied back in June for the use of its immunizers on children aged 5 to 11, and on adolescents aged either 12 to 15 or 16 to 17 years.

“The documentation consists of clinical data, which should support the technical decision, confirming that the benefits outweigh the risks in the application of the booster dose in this age group,” Anvisa said in a statement released late Thursday.

According to the agency, the request for additional information includes the Risk Management Plan of the Comirnaty vaccine regarding booster doses in these age groups. “The analysis of the requests will be finalized only when the referred documentation is made available and analyzed,” insisted Anvisa. Wyeth/Pfizer was given 120 days to comply.

Meanwhile, the COVID-19 Panorama released Friday showed all early indicators of the malady were on a downward trend, according to Rio de Janeiro's State Health Secretariat (SES) data collected between July 11 to 17.

In the week from July 4 to 10, the daily average of people seeking medical help for COVID-19 reached 489, of which 275 were adults. In the July 11-17 week, the daily average of patients was 296, with 155 of them being adults.

“All indicators for COVID-19 have been showing a sustained decline. Attendances to cases of influenza syndrome reduced approximately 40% in relation to the previous week, which indicates that we are in a phase of decline in the transmission of covid-19,” said RJ Health Secretary Alexandre Chieppe.

Between July 11 and 17, an average of 6,000 antigen tests were performed daily, with a positivity rate of 15%. As for the RT-PCR, an average of 350 tests per day are being analyzed, with positivity standing at 14.4%. In the week from July 4-10, the positivity of the antigen tests was 21% and the positivity of the RT-PCR exams was 18%.

(Source: Agencia Brasil)