Russia's Gamaleya seeks to amend EUA of COVID-19 vaccine
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.
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)
Health Officer-in-Charge Maria Rosario Vergeire says the general population may now get their second booster jab.
"We're just waiting for the release of implementing guidelines, then we'll start rolling out our second booster for the general population," she says. — Gaea Katreena Cabico
Amid questions on vaccines being administered, the Department of Health assures the public all doses are safe and effective as the “process of extending shelf life goes through thorough stability studies.”
“The government ensures that every vaccine that is injected with an extended shelf life has gone through studies, and is still safe and effective against COVID-19,” it adds.
Government must increase vaccination capacity across the Philippines in anticipation of a surge of COVID-19 cases caused by the Omicron variant of the corona virus, Sen. Risa Hontiveros says.
She says local government units and the private sector can work together to put up more vaccination centers and deploy more vaccination teams to get more people inoculated against COVID-19.
"The active COVID cases have nearly doubled in three days. The positivity rate is almost four times the ceiling set by the World Health Organization. Huwag na nating hintayin na sobrang lumala pa ang sitwasyon bago tayo gumawa ng paraan para mapabilis ang ating pagbabakuna."
FDA chief Eric Domingo says that its agency has given emergency approval for the use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.
The United States immunized around 900,000 children aged five-to-11 against Covid in the first week the Pfizer vaccine was authorized for them, a White House official says Wednesday.
Roughly 700,000 more have made appointments at pharmacies, White House Covid coordinator Jeff Zients tells reporters.
"The program is just getting up to full strength," he says, adding most of the shots were given in the last couple of days alone. — AFP
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