US expects approval of Covid-19 vaccine in December
The US health secretary, Alex Azar, said on Tuesday morning that America hopes to have a coronavirus vaccine approved by December and tamped down Russia’s celebrations over unveiling its own vaccine after rapid development.
“The point is not to be first,” Azar said. “The point is to have a vaccine that is safe and effective for the American people and the people of the world.”
Daily Times reports that Russia approved a Covid-19 vaccine for widespread use after less than two months of human testing, including a dose administered to one of Vladimir Putin’s daughters.
Kirill Dmitriev, the head of the country’s RDIF sovereign wealth fund, said the vaccine would be marketed abroad under the brand name Sputnik V with international agreements to produce 500 million doses and requests for one billion from 20 countries.
READ ALSO: Russia starts testing of Coronavirus vaccines
The development was hailed by Putin as evidence of Russia’s scientific prowess, but the truncated testing regime has raised eyebrows elsewhere for skipping so-called phase 3 large-scale safety trials, which usually take months. Instead, phase 3 trials will be conducted in parallel with mass production of the vaccine, including in Brazil.
Azar said, “We need transparent data. It’s got to be phase 3 data that shows that the vaccine is safe and effective, and that’s what President Trump is leading with Operation Warp Speed.”
The project is the public-private partnership that is coordinating vaccine trials in the US. Azar told ABC’s Good Morning America show that six vaccines were in development and “we believe that we are on track towards having tens of millions of doses by December of FDA [Food and Drug Administration] gold-standard and hundreds of millions as we go into the new year”.
Top US public health expert Anthony Fauci, who sits on the White House coronavirus taskforce, has said he is “cautiously optimistic” about trials underway, but the trials would have to have their results before scientists will know if the US has a viable vaccine.
