FDA urged to grant full approval to best Covid-19 vaccines

By Filane Mikee Cervantes and Ma. Teresa Montemayor

May 20, 2022, 7:22 pm

<p><strong>BOOSTER SHOTS.</strong> Immunocompromised individuals, senior citizens, and medical workers receive second booster shots at V-Mall Greenhills in San Juan City on Friday (May 20, 2022). Experts recommend availing of booster doses as the efficacy of previous shots wanes over time. <em>(PNA photo by Joey O. Razon)</em></p>

BOOSTER SHOTS. Immunocompromised individuals, senior citizens, and medical workers receive second booster shots at V-Mall Greenhills in San Juan City on Friday (May 20, 2022). Experts recommend availing of booster doses as the efficacy of previous shots wanes over time. (PNA photo by Joey O. Razon)

MANILA – A party-list lawmaker on Friday urged the Food and Drug Administration (FDA) to grant full approval to the best of the coronavirus disease (Covid-19) vaccines which only have emergency use authorizations (EUA).

Senior Citizen party-list Representative Rodolfo Ordanes said the full approval would result in a jump in vaccination rates because of the "wider and easier availability" due to the issuance of the certificate of product registration.

To date, more than 68 million Filipinos have been fully vaccinated against Covid-19.

"Start with the Moderna and Pfizer vaccines which already have full approval in the USA for adults," Ordanes said in a statement.

He also asked the Department of Health (DOH) and FDA to expand the eligibility criteria for the second booster to include everyone under the A3 category or adults with comorbidities.

For now, only senior citizens, health care front-liners, and the immunocompromised subset (organ transplant, cancer, and human immunodeficiency virus/Acquired immunodeficiency syndrome patients, have primary immunodeficiency, and those who take immunosuppressants) are eligible for the second booster shots.

"Expanding the eligibility for the second booster will improve the protection of all the A3 (immunocompromised) because of their varying medical conditions," he said.

EUA for Convidecia

Meanwhile, the DOH said Friday that China's CanSino Biologics has applied for EUA of the single-dose Covid-19 vaccine Convidecia, following the World Health Organization’s (WHO) emergency use listing (EUL).

EUL assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality.

Convidecia is the 11th vaccine for Covid-19 validated by WHO.

In its news release Thursday, the WHO said it has reviewed Convidecia's data on quality, safety, efficacy, a risk management plan, and programmatic suitability. It also conducted a manufacturing site inspection before issuing the EUL.

Convidecia is based on a modified human adenovirus that expresses the spike S protein of SARS-CoV-2 (severe acute respiratory syndrome-coronavirus), the virus that causes Covid-19.

It was reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for use in populations.

SAGE recommends the use of the vaccine as a single (0.5ml) dose, in all age groups, 18 and above.  It was found to have 64 percent efficacy against symptomatic disease and 92 percent against severe Covid-19.

Complacency

Iloilo Representative Janette Garin said the government should improve the booster shot uptake among the eligible population as the DOH confirmed the local transmission of BA.2.12.1, a more contagious version of the Omicron Covid-19 variant.

"May mahigit 54.5 million na mga Pilipino na ang dapat na magpa-booster shot. Sa kasalukuyan, 25 percent pa lamang o 13.7 million pa lang ang nagpapa-booster. Kung ganito ang magiging pace ng ating pagbabakuna, maaring magkaroon na naman tayo ng surge sa mga susunod na buwan (There should be around 54.5 million Filipinos that should receive booster shots. Currently, only 25 percent or 13.7 million have received their first booster doses. If this booster rate continues, there would be another surge in the coming months)," Garin said in another statement.

She urged the public to "work together to keep this Covid subvariant at bay" by fighting against pandemic fatigue and being steadfast in following health protocols for everyone's safety and health.

"Naiintindihan ko na marami na ang pagod magsuot ng face mask, marami na ang hindi sumusunod sa health protocols dahil sa pandemic fatigue, marami na ang panay labas (I understand that many are tired of wearing face masks, many are no longer following health protocols because of pandemic fatigue, many are already going out) thinking there is no Covid-19 anymore. But this is not true. The pandemic is still real and it continues to threaten our economy and our way of living," she said.

Vaccine expert panel chairperson Nina Gloriani said booster shots of the Covid-19 vaccine are effective protection against the Omicron BA.2.12.1 subvariant.

She said the protection from the primary series of Covid-19 vaccines is not enough against Omicron subvariants BA.1 and BA.2.

“[The] mRna vaccines, very clear after two doses, ang efficacy nitong mga bakuna bumababa hanggang 10 percent against Omicron variant. 'Pag binigyan ng third dose, two to four weeks after bababa rin ito to about 59 to 75 percent. After another two months, bababa pa ng 51 to 64 percent and after three months, nasa 49 [to] 50 percent na lang (their efficacy goes down to 10 percent against Omicron variant. When given a third dose, two to four weeks after, it will also go down to about 59 to 75 percent. After another two months, it will go down to 51 to 64 percent and after three months to 49 [to] 50 percent),” she said in a previous interview.

Studies abroad showed waning immunity after the first booster or third dose, she added. (PNA)


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