The Department of Health (DOH) suspended Thursday the use of the AstraZeneca COVID-19 jab for people under 60 after reports of blood clots overseas, in a setback for the country’s already slow vaccine rollout.
The announcement comes amid a record surge in coronavirus infections that has forced more than 24 million people in the capital and surrounding provinces into a lockdown.
Several European countries have suspended the use of AstraZeneca’s vaccine for younger populations after it was earlier banned outright in several places over blood clot scares.
The EU’s medicines regulator said Wednesday blood clots should be listed as rare side effects of the jab, but the benefits continue to outweigh the risks.
“While we have not seen such incidents in the country, the FDA has recommended to temporarily suspend the use of the vaccine for persons below 60 years old as we await results of the review being done by our local experts, as well as the official guidance of the WHO,” FDA Director-General Eric Domingo said.
The Philippines has received around 2.5 million doses of COVID-19 vaccines so far -- the majority from China’s Sinovac.
It also got 525,600 AstraZeneca doses through the COVAX program, most of which have been administered already, according to official data.
The country expects another 3 million AstraZeneca doses in the coming months.
President Rodrigo Duterte’s government has been skewered by critics over its handling of the pandemic and efforts to secure vaccines.
The 2.5 million doses received so far represent a fraction of the shots Manila has been negotiating with seven manufacturers to secure.
The bulk of the supply is not expected until later this year.
But the challenge is not limited to stock.
Low public confidence in vaccines remains after the country became the first to deploy the dengue vaccine Dengvaxia in 2016.
A botched rollout led to claims that several dozen children had died from the jab, and a recent survey showed about 60 percent of the population were unwilling to be inoculated against COVID-19.
“I want to emphasize that this temporary suspension does not mean that the vaccine is unsafe or ineffective -- it just means that we are taking precautionary measures to ensure the safety of every Filipino,” Domingo said in the statement.
The World Health Organization’s Western Pacific office on Wednesday backed the use of the AstraZeneca vaccine in the region.
“Available data do not suggest any overall increase in the clotting conditions in the vaccinated population as compared to the general population,” Socorro Escalante, WHO essential medicines coordinator, told reporters.
The European Medicines Agency examined 86 blood clotting cases, 18 of which were fatal, out of around 25 million people in Europe who received the AstraZeneca vaccine. Most of the cases were in women aged under 60.
The DOH adopted the FDA recommendation to temporarily suspend the use of AstraZeneca vaccines for people aged below 60 years old.
Domingo said that those who were given AstraZeneca’s COVID-19 vaccine in the Philippines have yet to report a side effect of having a blood clot or a reduced platelet count.
Domingo said that with the country’s almost a million doses of AstraZeneca expected to be delivered next month, there is time for a comprehensive scrutiny.
“We almost used up our AstraZeneca supply. The next batch of AstraZeneca is expected to be delivered a month from now. That will give us the time to study the evidence and come up with new guidelines,” he said.
Based on the original FDA evaluation, AstraZeneca’s COVID-19 vaccine is good for people 18 years old and above and has an efficacy rate of 70 percent after the first dose—a rating that increases after the second dose is administered four to 12 weeks afterward.
The DOH and FDA assured the public that experts are carefully reviewing information pertinent to this new development to craft appropriate recommendations on the vaccine’s use.
To date, the National Adverse Events Following Immunization Committee(NAEFIC) has not received any local reports of such side effects. Nonetheless, the DOH and FDA are carefully monitoring the rollout of vaccines to identify and appropriately manage any possible adverse events, the two agencies said.
The National Task Force on COVID-19 and the DOH emphasized that vaccination is safe and free, and urged senior citizens and persons with co-morbidities to receive the available vaccines that their local governments acquire.
A day after approving the use of China’s Sinovac vaccine for the elderly, the FDA said the efficacy rate of the jab on senior citizens is at least 51 percent, but added that it should not be given to those with acute illness and uncontrolled hypertension.
“Based on what we saw on Phase 1 and Phase 2 and some Phase 3 (human) clinical trials in other countries, the efficacy rate [of Sinovac on seniors] is at 51 percent to 52 percent,” Domingo said.
“We [also] have 700 health workers aged 60 and above who got Sinovac because they signed a waiver, and the adverse events we saw were the usual,” he added.
“We can say the benefits outweigh the risk. That is why the DOH requested us to revise our recommendation, and also because we do not have other available vaccine brands alongside the high transmission rate,” Domingo noted.
However, he said that the use of Sinovac on elderly still has limitations. “This is not for those who have acute illness, uncontrolled hypertension, or hypertensive emergency.”
Based on FDA evaluation, Sinovac’s efficacy rate on clinically healthy individuals ranges from 65 percent to 91 percent.
Sinovac’s efficacy rate on health workers, however, is only at 50.4 percent, but he said 50 percent is a good enough threshold.
“The acceptable level for the World Health Organization (WHO) is 50 percent,” he pointed out.
Manila Mayor Francisco “Isko Moreno” Domagoso announced that the city of Manila on Thursday began inoculating senior citizens with China-made vaccine Sinovac.
Domagoso said the use of the said vaccine came about after the FDA reconsidered the recommendation of experts, the current situation of high COVID-19 transmission and the limited supply of vaccines.
Previously, only AstraZeneca was allowed to be given to senior citizens.
As of Wednesday, a total of 52,084 frontline workers, senior citizens and individuals with co-morbidities under the A1, A2 and A3 categories have so far been inoculated since the vaccination program of the city of Manila took off in the first week of March.
Meanwhile, Domingo said the Chinese firm Sinopharm has no pending application for emergency use authorization (EUA) of its COVID-19 vaccine.
Domingo said this a day after the Presidential Security Group, whose members were inoculated with Sinopharm jab, disclosed that at least 126 of PSG’s members got infected with COVID-19, and 45 are still on the active case list.
In December last year, President Rodrigo Duterte revealed that members of the PSG were inoculated with Sinopharm’s COVID-19 vaccine smuggled into the country.
PSG Chief Jesus Durante III later confirmed the President’s information, saying that the security group members inoculated themselves with Sinopharm.
Lawmakers have called for investigation on PSG members getting smuggled COVID-19 vaccines, but President Duterte said in a public address that the PSG should not cooperate with such a probe.
It was only in February this year that the FDA granted a compassionate use permit for 10,000 doses of Sinopharm vaccine for the use of PSG members.
Also on Thursday, Glovax Biotech Corp. said it was in talks with the MVP Group of Companies to supply COVID-19 vaccines to Smart Telecommunications, Manila Electric Company, MPIC Hospitals and PayMaya. “We have started talks since 2020 and we intend to supply these private companies of our COVID-19 vaccines since the government is already allowing the private sector to get their own supply,” said Glovax founder and CEO Giovanni Alingog. Glovax has recently secured about 40 million doses of the EuCorVac-19 which was developed in the US and produced in Korea by its technology partner Eubiologics Co. Ltd. With AFP
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