A PHILIPPINE government official said there is a need to conduct clinical trials on having a Covid-19 booster shots, as well as on determining whether one could use different vaccine brands for the first and second dose.
Undersecretary Rowena Cristina Guevara, of the Department of Science and Technology (DOST), said they and the Department of Health have agreed these studies have to be done. She said during clinical trials, experts will use same vaccine brand for the first and second doses and will use a different vaccine brand for the booster.
Guevara added that experts will also be studying the use of two
different vaccine brands for the first and second doses. “The protocol for the
study is still being finalized, and will need approval of the FDA (Food and
Drug Administration). The result of the study will be reported to the Vaccine
Cluster of the National Task Force against Covid-19 for appropriate action,”
she told the Philippine News Agency, adding, the studies will start this year
and may last for up to two years.
She said these studies will answer important and practical
scientific questions about the government’s vaccine rollout and strategy. “Is
there a combination that will yield better immunogenicity? This is among the
questions that could be answered through the study,” Guevara said.
The experts, she said, will also analyze the immune response over
time. She said while some vaccines have been granted the FDA Emergency Use
Authorization, experts do not know yet how long the protection from these
vaccines could last.
When asked if using two different brands would not be costly for
the government since it has already procured two doses of the same brand for
each recipient, Guevara said, “we are looking at efficacy and safety, rather
than cost.”
She said the study will also determine how the government could
minimize the impact of any potential delivery delays.
Health Undersecretary Maria Rosario Vergeire said having a booster
shot could help strengthen one's immune response to the virus, while the study
on using two different vaccine brands would see if an immune response could
still be produced.
DOST Secretary Fortunato de la Peña said it has
allocated P133 million for the project study and will begin this June and will
run for 18 months. “The study aims to contribute to addressing the Covid-19
vaccination concerns in the Philippines associated with the unpredictable
vaccine supply,” he said.
The study also aims to determine if the high-risk
population who completed the dosing regimen of a vaccine would show a better
immune response after getting a booster dose. According to De la Peña,
the safety and immunogenicity of completing the vaccine shots from the
available Covid-19 vaccines in the country will be evaluated on those given
Sinovac as the first dose.
“Combination of Sinovac vaccine with other vaccine
brands will be the main aim of the study due to it being the most stable vaccine
supply in the country,” he said.
Adverse events, he added, will be monitored and
evaluated as part of the study’s safety assessment. Antibody tests, on the
other hand, will be done in five different time points to assess the
immunogenicity of the different vaccine combinations.
De la Peña pointed out that the local clinical
data to be generated from this study can serve as the basis for the Department
of Health's guidelines on the vaccination rollout, especially during limited
vaccine supplies or vaccine shortage.
The study will be led by Dr. Michelle De Vera, of
the Philippine Society for Allergy, Asthma, and Immunology, he said.
There are eight proposed study sites nationwide. (Maria Cristina Arayata)
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