Sputnik V to be registered with FDA as single-dose vaccine

Food and Drug Administration director-general Eric Domingo said Monday that the Gamaleya Institute had submitted a request to the FDA to change some details on registering the Sputnik V vaccine in the Philippines.

Sputnik V is one of 8 vaccine brands that have been given emergency use authorization (EUA) by the FDA for use in the country.

“Iyong Sputnik vaccine, ito po iyong 2-dose vaccine na adenoviral vector na magkaiba,” said Domingo.

“They have already written us to say that they might be amending the emergency use authorization para habaan ang time interval between the 2 doses, parang very similar sa adenoviral vaccine natin na Astrazeneca, which we give in 12 weeks.”

In addition, they also want to make the vaccine a single-dose vaccine.

“They are also thinking of registering the vaccine as single-dose vaccine similar to the Janssen vaccine na single dose na binibigay . . . And we are waiting for the data to support this kung acceptable siya,” Domingo added.

When it comes to other vaccine brands, Domingo admitted that based on studies abroad, it appears that only Pfizer and AstraZeneca are still guaranteed to be effective against the more infectious Delta COVID-19 variant.

Sputnik V to be registered with FDA as single-dose vaccine

“So far the data for Pfizer, shows that for the UK variant, for the Pfizer vaccine nareretain niya iyong mataas na efficacy rate niya of 93%, pagdating sa Delta variant, although bumababa ng kaunti mayroon pa ring 88% na effficacy sa Delta,” he said.

“There is a decreasing efficacy as we get more mutation but hindi naman po nawawala ng completely ang bisa ng bakuna. It is a useful vaccine.