Philippines approves emergency use of J&J, Bharat Biotech COVID-19 vaccines

Marje Pelayo   •   April 20, 2021   •   333

MANILA, Philippines – The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the COVID-19 vaccines of Bharat Biotech International and Janssen Pharmaceuticals, FDA Director General Eric Domingo confirmed Monday (April 19).

The agency, however, has not released details on the indication and contraindication of the vaccines as well as the procedure of administration and to whom it should be prescribed.

India’s Bharat Biotech is known for its Indirab rabies vaccine while Janssen Pharmaceuticals is the medical research and pharmaceutical product development arm of the New Jersey-based American corporation Johnson & Johnson.

To date, six pharmaceutical companies have applied and have been granted EUA for their vaccines in the Philippines.

These are Pfizer Biontech, Gamaleya, Astrazeneca ,Sinovac , Bharat Biotech and Janssen.

FDA warns against use of veterinary drug Ivermectin to treat COVID-19

Marje Pelayo   •   March 18, 2021

MANILA, Philippines – The Food and Drug Administration (FDA) has issued a warning against the use of veterinary medicine  Ivermectin as treatment for COVID-19.

In an advisory, the FDA said that Ivermectin is approved only for use in animals through “oral and intravenous preparations.”

The agency explained that the drug is being used for the prevention of heartworm disease and treatment of internal and external parasites “such as head lice and skin conditions such as rosacea” in certain animal species.

“The drug is an important part of a parasite control program for some animal species and should only be administered according to its approved indication, or as prescribed by a duly licensed veterinarian,” the agency noted.

“The public is warned against taking animal drugs, as the FDA has only evaluated their safety and efficacy in the particular species for which they are labeled. Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” the agency added.

The FDA said that “registered Ivermectin products in the country for human use are in topical formulations under prescription use only” which means it cannot be taken orally but can only be applied on the human skin.

The agency stressed that Ivermectin has not been approved by the FDA “for treatment of any viral infection.”

“Any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 should be avoided as the benefits and safety for this purpose has not been established,” the agency said.

FDA to visit Gamaleya’s manufacturing facility in Russia for Sputnik’s EUA application

Marje Pelayo   •   March 11, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) is continuously coordinating with Russia’s Gamaleya Research Institute for the requirements needed for the pharma firm’s application for emergency use authorization (EUA) in the Philippines.

The Russian drug company still lacks one requirement which opted the FDA to visit its facility in Russia to verify for itself if Gamaleya is compliant with the standards in manufacturing the COVID-19 vaccine Sputnik.

Gamaleya submitted its application for EUA on January 7 which until today, has not been approved by the FDA.

One document that the firm needs to provide is the certificate of good manufacturing practice, according to FDA Director-General Eric Domingo.

“Sila naman din ang nag-offer na mag-inspect na lang ang Philippine FDA the same with what other countries have done with their manufacturing facility. Iyon na ang naging kasunduan,” Domingo said.

“Ang inspection kasi titingnan mo ang findings, sabihan mo sila kung meron silang kailangang i-correct or kailangang i-explain sa amin kung ano ang measures nila to be sure na iyong findings namin ay ma-address,” he added.

Regulatory inspectors are set to fly to Russia next week.

Once all requirements are complete, the FDA may approve Gamaleya’s EUA for the vaccine Sputnik.

“Ang gusto naman natin matapos na within the month of March kasi ang plano nmin pupunta sila ng March 15 to 18 and the gagawa pa ng report doon it may take a few days after that,” Domingo said.

“Hopefully ang gusto ko matapos na sya within the month of March,” he added.

To date, aside from Gamaleya, another pharmaceutical company with pending EUA application with FDA is India’s Bharat Biotech. – MNP (with reports from Aiko Miguel)

Duterte ‘puzzled’ over FDA advice on Sinovac use for health workers – Palace

Robie de Guzman   •   February 24, 2021

MANILA, Philippines – President Rodrigo Duterte was perplexed by the recommendation of the Food and Drug Administration (FDA) not to use the Sinovac COVID-19 vaccine on health workers who are frequently exposed to patients with coronavirus disease (COVID-19), Malacañang said Wednesday.

Presidential Spokesperson Harry Roque said the president has asked FDA Director-General Eric Domingo to explain such recommendation after the agency’s issuance of an emergency use authorization (EUA) to Sinovac.

“Si president po mismo, nagtataka bakit nga ganuon nga ang naging EUA ng FDA at pinatawag po talaga si Dr. Domingo ng huling cabinet meeting… Naiparating ng president ang pagtataka kung bakit may ganitong colatilla,” Roque said.

Domingo explained that the vaccine’s efficacy rate on healthcare workers is 50.4% based on Sinovac’s clinical trials conducted in Brazil, making it not the best vaccine suited for healthcare workers treating coronavirus patients.

The FDA chief, however, stressed that this is only a recommendation and healthcare workers are not prohibited from receiving Sinovac if they chose to.

“Nirerespeto po ni president ang mga opinion ng mga experts kaya let the colatilla remain,” Roque said. – RRD (with details from Correspondent Rosalie Coz)

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