MANILA (2nd UPDATE) — The Philippines on Thursday suspended the use of AstraZeneca’s COVID-19 vaccine for those below 60 years old due to reports of rare blood clots in some individuals who received the product abroad.
The country's health department said it is adopting the recommendation of the Food and Drug Administration (FDA) to temporarily halt the use of the product as a precautionary measure "to ensure the safety of every Filipino."
“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,” FDA Director General Eric Domingo said in statement.
The Philippines has received an initial shipment of 525,600 doses of the AstraZeneca vaccine through the COVAX Facility. It is the second vaccine brand delivered to the Philippines, after Sinovac's from China, the rollout of both had already commenced.
“We are aware of the recommendation of the European Medicines Agency (EMA) to list blood clots as very rare side effects of the AstraZeneca vaccine. 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,” Domingo said.
The Philippines’ National Adverse Events Following Immunization Committee (NAEFIC) has not received any local reports of such side effects, the DOH statement said.
But both the DOH and FDA are "carefully reviewing" the information from abroad "in order to craft appropriate recommendations on the vaccine's use," it added.
In a public briefing, Domingo said the EMA recorded “very, very rare” cases of blood clots in out of 200 million people vaccinated with the AstraZeneca jab.
Most of those who reported blood clots overseas were women below 60 years of age, he said.
“Kung meron pa pong natitirang AstraZeneca vaccine, siguro ay ‘wag muna nating gamitin sa mga people below 60 years old until bigyan [tayo ng] clearer evidence at saka clearer guidance from WHO at saka sa atin pong mga expert.”
(If we still have AstraZeneca doses left, let's not give it for now to people below 60 years old until we are given clearer evidence and guidance from the World Health Organization and our experts.)
According to Domingo, almost all of the doses of the AstraZeneca vaccine supply in the country have already been administered.
Before this week, AstraZeneca was the only vaccine in the Philippines that could be administered to those 60 years old and above. But with the limited supplies of the vaccine, the FDA decided on Wednesday to allow the use of Sinovac's product for senior citizens despite the lack of evidence that it is effective for the said age group.
Asked what will happen to those who already received their 1st dose of the AstraZeneca vaccine, Domingo said: "The review will be completed before the schedule of the second dose."
Domingo said the country's next delivery of the UK-developed vaccine might arrive in May.
“That will give us time to study the evidence and to see kung magkakaroon po tayo ng bagong guidance sa paggamit ng AstraZeneca vaccine,” said the FDA chief.
(That will give us time to study the evidence and to see if we will release new guidance for the use of the AstraZeneca vaccine.)
Presidential Adviser for Entrepreneur and Go Negosyo Founder, Joey Concepcion, however, insisted the country should focus on the benefits the AstraZeneca jabs can use, against the risks.
“Of course, any information like this is a point of concern. Most especially, we are expecting around 22 to 26 million total combined doses of AstraZeneca from the COVAX facility, LGUs, and private sector procurement. Also, most of the workforce in the private sector belongs to the age group below 60, same with the LGUs and other sectors, so this greatly affects a lot in our population," he said in a statement.
"Vaccinating these sectors is very vital for the goal of our vaccination program, failing to meet these goals might have a direct hit in the economy,” added Concepcion, who doesn't have a medical background.
The Philippines has received 2 million doses of the Sinovac product, putting the country's total COVID-19 vaccine stock at over 2.5 million doses.
As of April 6, nearly 923,000 doses of both Sinovac and AstraZeneca vaccines have been administered all over the country.
Of the 923,000 administered, 493,688 are AstraZeneca.
At least 31,912 doses from the UK-based drugmaker are remaining in the Philippines, said Restituto Padilla, spokesperson of the National Task Force (NTF) COVID-19.
The DOH and the FDA reiterated to the public that vaccination in the country is safe and free.
Among the worst hit by the pandemic in Asia, the Philippines aims to vaccinate up to 70 million people or two-thirds of its population this year to achieve herd immunity against the coronavirus.
A recent surge of infections have raised the country's total COVID-19 cases to 819,164, of which 158,701 remained active as of Wednesday.
More than a dozen countries have at one time suspended use of the vaccine, which has been given to tens of millions in Europe. But most have resumed, with some, including France, the Netherlands and Germany, recommending a minimum age.
European Union health ministers failed to agree on common guidance on the use of the shot, despite calls for coordination across member states to combat public hesitancy over a vaccine set to be a key component of many vaccination programs.
The EMA received reports of 169 cases of the rare brain blood clot by early April, after 34 million doses had been administered in the European Economic Area. The EEA comprises the 27 EU countries plus Iceland, Norway and Liechtenstein.
But experts say that, even if a causal link is proved, the risks of getting a serious clot are vanishingly small compared to the risks from possible COVID-19 infection, which can cause similar clots along with other serious symptoms.
The shot has faced questions since late last year, when the drugmaker and Oxford University published trial data with two different efficacy readings as a result of a dosing error.
Among possible causes for the rare cerebral sinous vein clots being investigated are that the vaccine triggers an unusual antibody in rare cases or a possible link with birth control pills. But there is no definitive evidence.
Many experts say it is not clear whether or why AstraZeneca's vaccine would cause a problem not shared by other vaccines that target a similar part of the virus.
— With a report from Reuters