DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019   •   1463

A Filipino nurse prepares to administer an anti-dengue vaccine during a nationwide vaccination at a school in the flood-prone city of Marikina, east of Manila, Philippines, 04 April 2016. (Photoville International / FILE)

The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

WHO reiterates need to address vaccine inequity to end COVID-19 pandemic

Aileen Cerrudo   •   September 15, 2021

The World Health Organization (WHO) continues its call to address vaccine inequity in hopes to end the coronavirus disease (COVID-19) pandemic.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus, in his speech on Tuesday evening (September 14), lamented that of the more than 5.7 billion doses that have been administered globally, only less than 2% have been administered in Africa.

He said that Africa has been left behind when it comes to vaccine rollout.

“There are countries with less than two percent vaccination coverage, most of them in Africa, who are not even getting their first and second dose,” Tedros said.

Dr. Tedros said the lack of vaccines in Africa has a global impact that should be addressed.

“The longer vaccine inequity persists, the more the virus will keep circulating and changing, the longer the social and economic disruption will continue, and the higher the chances that more variants will emerge that render vaccines less effective,” he said.

The WHO calls on vaccine manufacturers to prioritize COVAX and the African COVID-19 Vaccine Acquisition Task Team (AVAT). It also calls on countries that have already achieved high coverage levels to swap their near-term vaccine deliveries with COVAX and AVAT.

The organization’s global targets are to support every country to vaccinate at least 40% of its population by the end of this year, and 70% of the world’s population by the middle of next year. AAC

Pateros LGU begins COVID-19 vax registration for minors aged 12-17

UNTV News   •   September 10, 2021

MANILA, Philippines — The local government of Pateros has opened the COVID-19 vaccination registration for  children aged 12 to 17.

The registration is only open to minors residing in the municipality.

The Pateros municipal government earlier called on parents and guardians to register their children for vaccination by using the QR code it posted on its official social media account.

Pateros Mayor Miguel Ponce III earlier said that those who registered early will be given priority once the vaccination for minors begins and additional supplies are available.

The Philippine Food and Drug Administration (FDA) has allowed the emergency use of Moderna and Pfizer vaccines for minors.

FDA director general Eric Domingo lauded the local government’s initiative ahead of the possible vaccination roll out for adolescents.

“It’s a great initiative on the part of the LGU na ngayon pa lang mag-umpisa na silang magregister ng mga adolescents, kasi darating naman talaga tayo doon. Darating din naman yung panahon na magbabakuna ng mga bata,” he said.

“It would be good, I think, for LGUs to prepare para kapag sinabi ng DOH na okay we have enough, pwede na tayong mag-vaccinate ng adolescents, pwede na agad islang makapag-rollout,” he added.

The government earlier said it may gradually include children in the COVID-19 vaccination program in the fourth quarter of the year when the Philippines gets the bulk of vaccine supply.

The country’s current vaccine supply is only allocated for priority groups, including healthcare workers, senior citizens, persons with underlying medical condition, essential workers, and indigents.

“Low -risk pa rin ang mga bata bagama’t nagkakaroon ng maraming cases across all ages pati sa mga bata, sila pa rin ang lowest risk of getting COVID and lowest risk of getting severe COVID” Domingo said.

Booster shots not yet recommended in PH amid short supply of vaccines

Aileen Cerrudo   •   August 16, 2021

MANILA, Philippines—Booster shots are still not recommended in the Philippines, according to National Task Force (NTF) Against COVID-19 chief implementer and vaccine czar Secretary Carlito Galvez Jr.

During the Laging Handa public briefing, Galvez said the recommendation for booster shots will depend on the supply of COVID-19 vaccines in the country while noting the global shortage and citizens who have yet to receive their first dose.

“This is still forbidden, booster shots, considering nakita natin napakaliit pa ng porsyento ng ating population na fully vaccinated. Nakita natin na more than 10 percent pa lang ang atin ang fully vaccinated and there 90 million Filipinos who are still waiting to be vaccinated,” he said.

Department of Science and Technology (DOST) Vaccine Experts Panel head Dr. Nina Gloríani said booster shots are recommended to be taken nine months or a year after receiving the second dose. It would also depend on the brand of COVID-19 vaccine. She also said the country should first achieve herd immunity before recommending booster shots.

Huwag tayong magmadali. Bigyan natin ang mga kababayan natin ng chance na makapagpabakuna rin para ma-achieve natin ang population protection, (Let us not rush. Let us give oour fellowmen a chance to get vaccinated and achieve population protection) and ultimately, ang herd immunity,” Gloríani said.

The vaccine expert panel is still reviewing whether to provide booster shots for immunocompromised citizens.

Meanwhile, Malacañang said they will hold accountable those who are getting unauthorized booster shots.

Presidential Spokesperson Harry Roque Jr. urged the public to wait for more citizens to be vaccinated. However, the national government said it can make an exemption for overseas Filipino workers (OFWs), and seafarers.

“Antayin muna natin mabakunahan ang karamihan ng ating mga kababayan bago tayo magbooster shot, siguro we can make an exemption doon sa mga OFW sa mga seafarers na kinakailangang magpabakuna ng western brands kasi iyon naman po ay requirement ng kanilang employers,” he said. AAC (with reports from Janice Ingente)

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