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AstraZeneca vaccine approved for rollout

The Philippine Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to British-Swedish drugmaker AstraZeneca for its coronavirus disease 2019 (Covid-19) vaccine.

An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of British pharmaceutical company AstraZeneca on November 17, 2020. / AFP / JUSTIN TALLIS

AstraZeneca is the second vaccine maker to get the green light to supply the country with a Covid injection.

FDA Director General Rolando Enrique Domingo said during a briefing on Thursday that the firm’s AZD1222 vaccine had a 70-percent efficacy rate after the first dose in phase three clinical trials.

Domingo said the AZD1222’s efficacy rate will increase when the second dose is administered, and the FDA recommended a standard dosage of 0.5 milliliter given from four to 12 weeks.

The side effects are at par with common vaccine reactions, he said.

Domingo said only patients over 18 years old can receive AZD1222 shots, and pregnant women must consult first with their doctors if they can be given the vaccine.

With the EUA, AstraZeneca can now supply its vaccine to the Department of Health (DoH) and other designated end-users such as local government units, public and private hospitals, and DoH partners, Domingo said.

It must also comply with cold-chain requirements and a comprehensive protocol to assure that the vaccine’s adverse events are monitored.

The Philippines ordered 20 million doses of AZD1222. Most of the allocation is divided between the national government, the private sector and local government units, based on agreements signed by vaccination czar Secretary Carlito Galvez Jr., Presidential Adviser for Entrepreneurship Jose Maria Concepcion 3rd and AstraZeneca Philippines President Lotis Ramin.

Earlier this month, an EUA was issued to Pfizer and BioNTech for their tozinameran vaccine.
Still lining up for an EUA are the Gamaleya Research Institute, Sinovac Biotech Ltd. and Bharat Biotech.

Gamaleya submitted additional interim data from its phase three clinical trials on January 21 while Sinovac submitted theirs two days earlier.

Bharat Biotech has yet to submit phase three data.

Domingo said three other drugmakers — Sinovac, Janssen Pharmaceutical and Clover Biopharmaceuticals — are scheduled to start phase three clinical trials in the country within weeks.

The DoH and the Department of Science and Technology are also set to submit its application for the Vaccine Solidarity Trial organized by the World Health Organization.
On Thursday, the DoH recorded 1,169 new Covid-19 cases, bringing the total number of cases to 519,575.

Quezon City led the cities and provinces in new cases with 57 each. Isabela had 54 cases, and Manila, Davao City and Rizal 42 cases each.

Recoveries totaled 475,596, and the death toll was at 10,552.


Source: ManilaTimes
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