Gamaleya seeks to extend interval between Sputnik V doses

MANILA – Russia’s Gamaleya Institute, manufacturer of the Sputnik V, is seeking to amend the vaccine’s emergency use authorization (EUA) to extend the interval between the two doses, Food and Drug Administration (FDA) Director General Eric Domingo said Monday.

The current interval between the first and second doses for the Russian-made vaccine is 21 days, the shortest among all adenovirus-vector vaccines allowed for emergency use. 

“’Yung Sputnik vaccine, ito po ‘yong two-dose vaccine na adenoviral vector na magkaiba (this is the two-dose vaccine adenoviral vector that is different). They have already written us to say that they might be amending the EUA to lengthen the time — time interval between the two doses,” Domingo said during a briefing with President Rodrigo Duterte.

In a statement posted on Sputnik V’s website, Alexander Gintsburg, the director of the Gamaleya National Research Center of Epidemiology and Microbiology, said the interval between the first and second doses can be extended from 21 days to three months. 

“We also believe that, given the exceptionally high demand for the vaccine among the population, this decision would significantly expedite immunization. We believe that it is up to each national regulator to decide whether to retain the 21-day interval between shots or to extend it to up to 3 months,” the statement read.

This will not affect the quality of vaccination and will make immune response stronger in some cases, he said.

Among the vaccines given EUA in the country, AstraZeneca, a viral vector vaccine, is the only Covid-19 vaccine with 12 weeks interval between doses.

“So, hinihintay lang po natin ‘yong scientific data ‘no to support the claim na mas maganda ‘pag pinapahabaan po ‘yong (we’re just waiting for the scientific data to support the claim it is better to lengthen the) time interval,” Domingo said.

He added that Gamaleya Institute is also considering to register Sputnik V as a single dose vaccine, like Johnson & Johnson’s Janssen which is also an adenoviral vector shot.

“And we are waiting for the data to support this kung acceptable siya (If it is acceptable),” he said.

The FDA has granted Spuntik V an EUA last March 19.

To date, the FDA has granted EUA to eight Covid-19 vaccine brands – Pfizer-BioNTech, Oxford–AstraZeneca, Sinovac, Sputnik V, Janssen, Covaxin, Moderna and Sinopharm.