PHILIPPINE authorities on Friday issued separate clarifications on two vaccines—by AstraZeneca and Sinovac—following what were seen as confusing signals on their use for senior citizens, one of the priority groups for immunization against Covid-19, and for those below 60.
Food and Drug Administration (FDA) Director General Rolando Enrique Domingo on Friday said that they will continue to administer the AstraZeneca Covid-19 vaccines on 60 and above, noting that the reported blood clotting was “not seen” on senior citizens.
“On the cases investigated, they are below 60. So, we are not really thinking to limit, to limit it on senior citizens,” Domingo said in a mix of Filipino and English in an online briefing of the Department of Health (DOH).
His statement was corroborated by Health Undersecretary Maria Rosario Vergeire, who said that, to date, they have not received any report of blood clotting after AstraZeneca was administered.
Sinovac’s case
Also on Friday, the Task Group on Vaccine Evaluation and Selection led by the Department of Science and Technology (DOST) issued guidance “on the recommendation to approve the use of CoronaVac [Sinovac’s vaccine] for adults 60 years old and above.”
The FDA had recently approved DOH’s request on the use of the vaccines for adults 60 years old and above, after earlier saying it was not recommended for such age bracket.
In its Friday statement, the task force led by the Department of Science and Technology, which oversees the Vaccine Expert Panel, pointed out this qualification, though: “While the general safety profile of the [Sinovac] vaccine based on available data is deemed to be acceptable, the FDA reiterates that their guidance may change and evolve as more efficacy, immunogenicity and safety data become available. Following FDA’s condition on the matter, vaccination of CoronaVac for a senior citizen will only be made after careful evaluation of the health status and exposure risk of the individual to ensure that the benefits outweigh the risk. Special attention will also be given to hypertensives.”
The surge of cases in the National Capital Region (NCR) and neighboring areas and limited supplies of vaccine had earlier led the DOH to ask the FDA to evaluate CoronaVac (Sinovac) on the possibility of recommending its use to eligible population 60 years old and above who are deemed part of the most vulnerable populations; this was the basis of the guidance given to allow Sinovac for senior citizens 60 and above.
‘Temporary suspension’
On Thursday, the DOH said the use of AstraZeneca vaccines for individuals aged below 60 years old, will be temporarily suspended following the recommendation of FDA due to recent reports of “rare cases of blood clots” with low platelets detected in some individuals inoculated with the vaccine.
“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,” Domingo said then.
Domingo said they will await the results of the review being done by the local experts, as well as the official guidance the World Health Organization (WHO).
However, Vergeire said that currently, there is no more supply of AstraZeneca in the country.
“The World Health Organization gave assurance that the Philippines will get another batch of AstraZeneca vaccine doses through Covax Facility by end of April,” Vergeire added.
Assessment of MHRA and EMA
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and European EMA completed on April 7 their assessment of extremely rare blood clotting events with low platelets from over 34 million people vaccinated with AstraZeneca’s vaccine in the UK and EU on April 7.
“Neither the UK nor EU regulatory agencies identified any risk factors, such as age or gender, or a definite cause for these extremely rare events. However, they came to the view that these events have a possible link to the vaccine and requested they be listed as an extremely rare potential side effect,” the statement of AstraZeneca Philippines read.
Overall, the company said both reviews affirmed their vaccine offers a high-level of protection against mild, moderate and severe forms of Covid-19 and that these benefits continue to far outweigh the risks.
In addition, it quoted the WHO as saying that, based on current information, a causal relationship is considered plausible but is not confirmed, adding that further specialized studies are needed to fully understand the potential relationship between vaccination and possible risk factors.
Image credits: AP/Matthias Schrader
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