Covid Vaccine Needs Approval First – DoH – The Manila Times



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‘What the private sector did was an early commitment’

A vaccine for the 2019 coronavirus disease (Covid-19) destined for distribution in the Philippines in mid-2021 will first have to be approved by a regulatory panel, a Department of Health (DoH) official said on Saturday.

A DOSE OF HOPE (From left to right) the Presidential Advisor for Entrepreneurship and founder of Go Negosyo, Joey Concepción 3rd; the czar of the vaccines Carlito Gálvez; and Lotis Ramin, National President of AstraZeneca Pharmaceuticals Philippines Inc., pose for photos with shots of some of the Philippines’ top business leaders on a giant multi-panel screen after signing a deal involving the private sector to purchase a Covid-based vaccine. AstraZeneca 19 on November 27, 2020. CONTRIBUTED PHOTO

The Undersecretary of Health, María Rosario Vergeire, said that all vaccines must obtain proper approval before they can be used in the country.

Vergeire echoed the vaccine czar and the secretary general in charge of the implementation of Covid-19, Carlito Gálvez Jr., who represented the government in the signing of the agreement with the British manufacturer AstraZeneca, along with the founder and presidential advisor of Go Negosyo for entrepreneurship, José María Concepción, third. who represented the private sector on Friday.

The P600 million deal calls for the delivery of 2.6 million doses of AZD1222 vaccine to 1.5 million Filipinos between May and June 2021.

Concepción said Friday that the AstraZeneca deal “was worth the risk” compared to “a much greater loss to the economy.”

“The private sector is putting its money to be part of the first batch of vaccines that will be delivered next year…. In a way, the private sector believes that it is worth the risk, and the sooner we can deploy the vaccines, with this cost, even with the risk of losing 50 percent, we believe that the loss for the economy is much greater ”, Concepción said during the signing ceremony.

He said concerns reported in the media regarding the vaccine’s 70 percent efficacy at two full doses and 90 percent efficacy at one and a half doses were still acceptable.

“From my own point of view, as an entrepreneur, I would take a risk because this is the first pharmaceutical company that has a very complete program for us to ensure vaccines from the beginning… These vaccines are worth the risk of betting, I think Astra and Oxford are a very trustworthy group and I think they will make it in the end, ”Concepción said.

Speaking at Laging Handa’s public briefing on Saturday, Vergeire said what the private sector did was a “forward compromise” to secure vaccine allocation.

He said that if the vaccine fails in the regulatory process of the joint panel made up of the Department of Health, the Department of Science and Technology and the Food and Drug Administration (FDA), it will not be distributed in the country.

He also reminded the private sector that all medical technologies entering the country, whether through government associations or the private sector, must first pass regulatory approvals before the private sector can acquire them for sale or distribution.
“There is [a] Regulatory oversight is our government.

We will not allow our market in case there is no FDA registration because we cannot be sure if it is safe or effective (the government has regulatory oversight. We will not allow [any medical product] on the market if there is no FDA approval, as we cannot be sure if it is safe or effective), ”said Vergeire.



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