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Friday, March 29, 2024

FDA grants J&J, Covaxin vaccines EUA for 18 above

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The Food and Drug Administration (FDA) has granted an emergency use authority (EUA) for COVID-19 vaccines made by Johnson & Johnson and Bharat Biotech’s Covaxin from India, the agency said on Tuesday.

FDA Director General Eric Domingo said both vaccines can be administered to people aged 18 and above in the Philippines.

The single-shot coronavirus vaccines developed by J&J's unit Janssen and Bharat Biotech's Covaxin are the fifth and sixth to receive EUAs in the Philippines, which is battling one of the worst outbreaks in Asia.

J&J is conducting late-stage clinical trials for its COVID-19 vaccine in the Philippines.

On Twitter, Indian Ambassador Shambhu Kumaran expressed thanks to Philippine officials for the approval of Bharat's EUA application for Covaxin.

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Vaccine czar Secretary Carlito Galvez, during a briefing chaired by President Rodrigo Duterte, announced that the FDA had issued the EUA for the Janssen vaccine.

Galvez also thanked the FDA for the approval of the EUA.

The FDA has found Bharat's vaccine is 95 percent and 92 percent effective on the study population and among all races, respectively.

Foreign Affairs Secretary Teodoro Locsin Jr. on Tuesday expressed gratitude to India after the Food and Drug Administration granted emergency use authorization for Covaxin vaccines against COVID-19.

“As if it’s a favor from us; the favor is to us,” the Locsin said on Twitter.

In a briefing, Domingo said the AstraZeneca COVID-19 vaccine has the most number of EUAs given by regulatory authorities around the world.

The AstraZeneca COVID-19 vaccine, developed by the British government and Oxford University, secured 91 EUAs, including one from the World Health Organization (WHO).

AstraZeneca was followed by Pfizer-BioNTech (United States) with 82, Gamaleya (Russia) with 62, Moderna (United States) with 46, and Janssen (United States) with 40, including WHO.

Sinopharm (Beijing), a Chinese brand, ranked sixth with 35 EUAs, followed by Covishield by Serum Institute of India with 33, including WHO.

Rounding up the rest of the field are Sinovac with 22 EUAs, Bharat BioTech’s Covaxin with six, Cansino with five, Anhui Zhifei Longcom’s RBD Dimer with two, FBRI EpiVacCorona and Sinopharm (Wuhan) with both two and Chumakov Center’s KoviVac with one.

Sinovac, Cansino and Zhifei and Sinopharm (Wuhan) are brands from China. FBRI EpiVacCorona and Chumakov Center’s KoviVac are brands from Russia.

In other developments:

* Opposition Senator Leila M. de Lima lamented that President Rodrigo Duterte does not bother to touch base with his United States counterpart on the matter of getting vaccines like Moderna and Pfizer, which can address COVID-19 and all its variants. "If he can do it with the Chinese or Russian presidents, why not the US President, the US being a friend and the Filipinos’ most trusted major ally?" De Lima asked. She noted that all it takes is a small ounce of humility and sincerity in seeking succor from the US and other Western countries, to augment the still very deficient supply of vaccines coming our way.”

* The Philippines has no report yet of death caused by COVID-19 vaccines, said Dr. Eileen Alikpala Cuajunco, of the National Adverse Events Following Immunization Committee (NAEFIC), in a report on ABS-CBN News. With Rey E. Requejo and Macon Ramos-Araneta

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