Moderna, Bharat Biotech COVID-19 vaccines won’t be allowed into PH until full EUA given
Video courtesy of Department of Health
MANILA — The Department of Health on Wednesday said it will ensure that health care workers will be trained to deal with adverse events after immunization (AEFI) as the Philippines approved the emergency use of Johnson & Johnson COVID-19 vaccines.
Like AstraZeneca, Johnson & Johnson’s vaccines have been linked to rare blood clotting cases. Despite this, the Philippine Food and Drug Administration (FDA) approved its emergency use authorization (EUA) application.
“Kailangan nating itrain ang ating health care workers so they can immediately recognize these adverse events among our citizens who will be vaccinated para tayo ay nandun sa safe side,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing, referring to those part of the vaccination teams nationwide.
(We need to train our health care workers so they can immediately recognize these adverse events among our citizens who will be vaccinated so we are on the safe side.)
Vergeire said experts and vaccine manufacturers are continuously studying the blood clotting events which are “very very rare side effects.”
Philippine government experts previously said AstraZeneca’s blood clotting cases were observed in only 4 people out of 1 million vaccine recipients. Meanwhile, the FDA said the Johnson & Johnson vaccine is linked to only 7 cases of blood clotting out of 7 million vaccinated people.
Vergeire said among the adverse effects that need to be monitored by health workers after vaccination are anaphylaxis, venous thromboembolism, and vaccine-associated enhanced disease.
Anaphylaxis is a severe allergic reaction to vaccine or vaccination components. This can result in difficulty in breathing and other symptoms. Venous thromboembolism or blood clots in veins can meanwhile result in serious illness or disability, according to the United States Centers for Disease Control and Prevention (CDC). Meanwhile, vaccine-associated enhanced disease is defined by the World Health Organization as “modified and severe presentations of clinical infections affecting individuals exposed to a wild-type pathogen after having received a prior vaccine against the same pathogen.”
Vergeire said international health institutions such as the WHO and the US CDC have already released statements pointing out that these are rare possible side effects.
BHARAT BIOTECH, MODERNA
Meanwhile, the health official assured the public that it will wait for India-based company Bharat Biotech to complete its EUA requirements before allowing its vaccines to enter the Philippines.
She said the company still needs to submit its good manufacturing practice certificate, risk management plan and other protocols to complete the FDA’s dossier.
Asked about the 194,000 vaccines expected from the American vaccine developer Moderna next month, Vergeire said the same rule applies.
“Hangga’t walang EUA ang isang produkto hindi pwedeng ipagamit sa ating populasyon,” she said.
(As long as a product has no EUA, it cannot be used by our population.)
Moderna has yet to apply for an EUA with the FDA.
Vergeire explained that since vaccines are still under development, the only assurance of the public that medical products are safe and effective are the EUAs being issued by the FDA.
She reiterated that products without EUAs cannot be brought into the country.
The Philippine government has been struggling to vaccinate as many Filipinos even with the limited number of doses in the country. Of the 3 million vaccines delivered to the Philippines, only 1.48 million have been administered. This, as the country experiences high numbers of COVID-19 cases, especially in Metro Manila and nearby provinces.