EUA application for Johnson & Johnson’s COVID-19 vaccine still under evaluation – FDA

Robie de Guzman   •   April 14, 2021   •   226

MANILA, Philippines – The emergency use authorization (EUA) application submitted by Johnson & Johnson for its pharmaceutical arm, Janssen’s COVID-19 vaccine is still under evaluation, the Food and Drug Administration (FDA) said Wednesday.

During a televised press briefing, FDA director-general Eric Domingo said the agency is looking into reports of rare blood clotting cases linked to Janssen vaccine in other countries.

“Ito kasing Janssen na bakuna very similar siya sa AstraZeneca, itong mga adenoviral vector vaccines. At ito nga ang nakikita na possible na very rare cases of blood clotting. So, kung matapos naman po ang evaluation nito at magkaroon ng recommendation of course, it will probably have recommendations din on how to guide vaccinators at iyong vaccines to watch out for such events at kung anong gagawin kung may naramdaman sila,” he said.

Domingo added that clinical trials using Janssen COVID-19 vaccine are still ongoing in the Philippines.

He said the FDA is carefully reviewing reports on its benefits as well as its health risks on a vaccine recipient.

“Pumasa rin naman siya sa US at saka sa WHO (World Health Organization), ibig sabihin, the benefit of using the vaccine definitely mas matimbang, outweighs the harm,” he said.

“Kaya naman po inaaral naman din natin kapag ganito, kina-calibrate din natin para kapag gagamitin siya ay nakahanda naman tayo kung paano ang tamang guidelines,” he added.  RRD (with details from Correspondent Aiko Miguel)

DOH studying possibility of mixing vaccine brands – FDA

Robie de Guzman   •   May 6, 2021

MANILA, Philippines – The Department of Health (DOH) is currently looking into the possibility of mixing different brands of vaccines against novel coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Thursday.

FDA director general Eric Domingo said the DOH is already drafting a set of guidelines that will allow a person to receive different brands of COVID-19 vaccines for first and second dose in case of severe allergic reaction and other adverse effects.

Aaralin po ngayon yan ng Department of Health, in fact, meron naman po talagang ongoing meetings ang Department of Health on that dahil meron po talagang instances na for example naturukan ka ng bakuna ng first dose tapos nagka-severe allergy ka so hindi ka na puwede sa second dose nun at kailangang isipin ngayon yung magiging alternative,” Domingo said during the Laging Handa briefing.

“Gumagawa na ng guidelines ngayon ang DOH kung paano ‘yung interchangeability or mixing ng vaccines in case the second dose cannot be given na identical doon sa first dose,” he added.

Domingo said this after President Rodrigo Duterte said he has requested China to recall the 1,000 doses of Sinopharm vaccines it donated following criticisms over his decision to receive a jab that has yet to secure an emergency use authorization from the FDA.

Duterte received his first dose of Sinopharm vaccine on Monday night.

Malacañang earlier said that the vaccine dose used on the president was covered by the compassionate special permit issued by the FDA for the Presidential Security Group.

FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19

Robie de Guzman   •   May 5, 2021

MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.

FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.

“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.

Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”

“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

Only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA also reiterated that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.

The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.

Philippines OKs emergency use of Moderna’s COVID-19 vaccine

Robie de Guzman   •   May 5, 2021

MANILA, Philippines – The Philippines has granted an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine, the Food and Drug Administration (FDA) said Wednesday.

FDA director general Eric Domingo said the regulatory agency approved Moderna’s application for EUA after conducting thorough review on data currently available, including those from adequate and well-known controlled trials.

Domingo said the vaccine will be administered to individuals aged 18 and above.

The Philippine government earlier said it has placed around 20 million COVID-19 vaccines from the US drug maker Moderna that will be split between public and private sectors. The initial batch of the shipment is expected to arrive by June.

The government targets to vaccinate up to 70 million people by the end of the year but due to the limited supply of vaccine doses, vaccine czar Carlito Galvez Jr. earlier proposed to prioritize the inoculation of areas with high cases to fend off further COVID-19 surges and enable the economy to recover.

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