Moderna distributor to apply for CPR

THE distributor of the Spikevax vaccine from Moderna said it will apply for a certificate of product registration to enable the commercial availability of the vaccine in the Philippines.

In an email interview with The Manila Times, Dr. Philip Nakpil, medical director of ZP Therapeutics Philippines, said it will apply for a CPR once it receives the relevant data regarding the safety profile of its vaccine and with the guidance of the Philippine Food and Drug Administration (FDA) and the Department of Health (DoH).

He stressed the importance of getting vaccinated against the Covid-19 virus, noting that the country continues to report more than 1,000 cases over the past two to three weeks.

“ZP Therapeutics supports all efforts of the national government in encouraging more Filipinos to get their booster shot... [We are also supporting] the call of the DoH to ensure the delivery of safe, effective and accessible vaccines for all Filipinos,” Nakpil said.

He added that booster shots are important to sustain immunity and reduce the severity of Covid-19 infections, noting that while the primary dose’ efficacy ranges between 76 percent and 92 percent in the first six months, it decreases to 34 percent to 80 percent after six months.

“Being boosted reduces Covid-19 infection by 69 percent and Covid-related hospitalizations and mortality by 69 percent and 97 percent, it also significantly reduces the severity of Covid infections, leading to lower hospitalization rates and death, which eases the burden on health care systems,” Nakpil said.

However, he said that the second booster shot remains only limited to specific populations such as the elderly and those who are immunocompromised as well as health care workers, noting that there is still limited data to support additional doses for healthy and younger populations.

Nakpil also said that the data from Moderna’s clinical trial has been “promising,” noting that it has elicited a five-fold increase in antibody protection versus the BA.4 and BA.5 subvariants of Omicron.

He said that ZP Therapeutics will “continue to monitor” the latest developments on the bivalent vaccine and coordinate with the drugmaker about its prospects in the region.

“We will also continuously engage with relevant stakeholders and regulators to ensure that we are compliant once the new vaccines are fit for market access.” Nakpil added.

DoH Officer in Charge Maria Rosario Vergeire said in previous media briefings that the Health department has begun discussions with Moderna, with the drugmaker giving a detailed dossier to the DoH, FDA and Health Technology Assessment Council for evaluation.