Brazil Approves Final Tests For J&J COVID-19 Vaccine
Brazilian health regulators have approved Johnson & Johnson’s experimental vaccine against the new coronavirus for the final stage of clinical trials.
The country’s health regulatory agency (Anvisa) in a statement said the US pharmaceutical company’s subsidiary Janssen will test the vaccine on 7,000 volunteers across seven states in Brazil, part of a group of up to 60,000 worldwide.
It said the test would be a randomized, controlled, double-blind Phase 3 trial or large-scale testing on humans — the last step before regulatory approval.
Anvisa official Gustavo Mendes in a video on the regulator’s website stated;
Another vaccine study has been approved in Brazil, which is a very important development.
Brazil has become a key testing ground in the search for a vaccine against COVID-19 since the virus is still spreading fast in the country.
The South American nation has the second-highest number of infections (more than 3.5 million) and deaths (110,000) in the pandemic, after the United States (over 5.6 million cases, 175,000 deaths).
Brazil has also approved three other Phase 3 trials of vaccine candidates, developed by Oxford University in partnership with pharmaceutical firm AstraZeneca, Chinese pharmaceutical firm Sinovac Biotech, and US firm Pfizer in partnership with Germany’s BioNTech.
This is fourth vaccine to receive widespread testing stage in the COVID-19 hard-hit country.
The Brazilian state of Parana has also signed a deal last week to test and produce Russia’s vaccine, which controversially became the first in the world to receive regulatory approval.
Russian vaccine called “Sputnik V” is named after the Soviet-era satellite that was the first launched into space in 1957.
It was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defence ministry.
Western scientists are sceptical, with some warning that moving too quickly on a vaccine could be dangerous, but Russia denounced criticism as an attempt to undermine Moscow’s research.