Russia's Gamaleya seeks to amend EUA of COVID-19 vaccine

Alexis Romero - Philstar.com
Russia's Gamaleya seeks to amend EUA of COVID-19 vaccine
This picture taken on November 23, 2020 shows a bottle reading "Vaccine Covid-19" next to the Russian Gamaleya National Center's logo.
AFP / Joel Saget

MANILA, Philippines — Russia's Gamaleya Institute, the manufacturer of COVID-19 vaccine Sputnik V, wants its emergency use authorization (EUA) amended to lengthen the interval between the two doses of its jab, the Food and Drug Administration (FDA) said.

"They (Gamaleya) have already written us to say that they might be amending the emergency use authorization to extend the time interval between the two doses," FDA director general Eric Domingo said during a meeting of the government's pandemic task force last Monday.

"This is very similar to the adenoviral virus... vaccine of AstraZeneca which we now give to12 weeks. We are waiting for scientific data to support the claim that it would be better if the interval (between the two doses) is lengthened," he added.

The FDA issued an EUA to the Russia-made vaccine last March. The interval between the first and second doses for Sputnik V is 21 days.

Domingo said Gamaleya is also thinking of registering Sputnik V as a single dose vaccine similar to that of American firm Johnson & Johnson.

"We are waiting for the data to support this, whether it is acceptable," the FDA chief added.

Domingo said India's Bharat Biotech has submitted all required documents, including the certification for good manufacturing practice. The company secured a conditional EUA last April.

"There’s no hindrance to them importing the vaccine into the Philippines, except of course, that they have to go through of course the vaccine czar and the Department of Health because it is under EUA. They cannot market directly to consumers...it always has to go through our vaccination program," Domingo said.

The manufacturer of the Novavax vaccine has submitted its preliminary data and the FDA is waiting for other requirements before it can continue its evaluation of the  jab, he added.

Domingo also reported that the vaccines from Pfizer and AstraZeneca remain effective against the new COVID-19 mutations.

Citing a recent study, Domingo said the Pfizer jab retained its 93 percent efficacy rate against the Alpha variant first detected in the United Kingdom. When it comes to the Delta variant first detected in India, the efficacy rate went down to 88 percent.

"So there’s a decreasing efficacy as we get more mutations, but the efficacy of the vaccine is not completely lost...It’s still a useful vaccine," Domingo said.

The AstraZeneca vaccine, meanwhile, recorded an overall efficacy rate of 66 percent against the UK variant and 60 percent against the Delta variant.

Domingo said studies about the efficacy of the Janssen, Moderna, Sinovac, Sinopharm, and Sputnik jabs against the Delta variant are ongoing.

"But initial reports indicate that they are also useful, but of course we expect that it will be a little lower than the original efficacy against the original variant. That means, none of the vaccines completely lost their efficacy even with the Delta variant," the FDA chief said.

"We should all get vaccinated with the vaccines that are available now. Because this will still protect us and will help us stop the spread even if (the Delta variant) comes," he added.

As It Happens
LATEST UPDATE: September 21, 2021 - 7:34am

The national government has so far secured two official deals for COVID-19 vaccine supplies in the Philippines, one with Chinese pharmaceutical company Sinovac and another with the Serum Institute of India.

Watch this space for bite-sized developments on the vaccines in the Philippines. (Main image by Markus Spiske via Unsplash)

September 21, 2021 - 7:34am

Cuba agrees to provide Vietnam with 10 million doses of its home-grown coronavirus vaccine, Abdala, for which the Asian nation has given emergency approval.

A deal was signed between the two countries during an official visit by President Nguyen Xuan Phuc to the communist island, the government says.

The agreement concerns an initial five million doses, but Vietnam has already authorized the purchase of 10 million doses in total, Cuban media reports. — AFP

September 3, 2021 - 11:37am

FDA Director General Eric Domingo says they have granted emergency use authorization approval for Moderna COVID-19 vaccines to be used in those aged 12-17 years old.

August 19, 2021 - 7:17pm

Under fire for its fumbled start in procuring Covid vaccines, South Africa now has plentiful jabs but faces a new challenge: tepid uptake.

With thousands of new infections and hundreds of deaths each day, South Africa has the biggest coronavirus tally of any country on the continent — more than 2.6 million cases in a population of 58 million.

The authorities have come in for hefty criticism for their vaccine strategy. In February, at a crucial point in the pandemic, the country notably turned down one and a half million doses of AstraZeneca vaccine over doubts that it would protect against a then-dominant local variant of the virus.

Since then, the government has secured tens of millions of shots, and South Africa even became the first nation in Africa to produce Johnson & Johnson and Pfizer jabs.

The goal is to vaccinate 70 percent of its adult population, or 28 million people, by end of the year. — AFP

August 9, 2021 - 8:01pm

The government of the Bangsamoro Autonomous Region in Muslim Mindanao has launched a web portal for constituents to register for vaccination against COVID-19, the Bangsamoro Information Office announces.

Dr. Bashary Latiph, health minister, says the portal (https://covid19.bangsamoro.gov.phis a result of the collaboration of the members of the Bangsamoro Inter-Agency Task Force on COVID-19.

The website shows also shows updated statistics of the region's vaccination efforts and information on COVID-19 cases.

The BARMM has fully vaccinated 144,153 individuals — 91,282 of them with the single-dose Janssen vaccine — the information office says.

August 5, 2021 - 8:50am

People have been flocking to malls in the city of Manila that have been designated as vaccination centers. According to reports by ABS-CBN News, some had lined up overnight to get a vaccination slot only to be told in the morning that not everyone will be accomodated.

Residents of Las Piñas also started lining up in the early morning of Thursday in the hopes of getting a vaccine dose, ABS-CBN News also reports. 

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