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FDA forms task force Edward to make COVID vac commercialized
By Nidz Godino
“Any post-market issues will be addressed through more rigorous surveillance and pharmacovigilance,” Food and Drug Administration Director General Dr. Samuel Zacate has launched task force that will pave way to make COVID-19 vaccines commercially available.
Taskforce Edward, named after British physician Dr. Edward Jenner who is known for his work on immunization, “aims to make safe and effective COVID-19 vaccines more accessible to Filipino people,” the FDA said.
Having task force will streamline approval and evaluation of COVID-19 vaccines, it stressed.
Government has previously issued emergency use authorizations (EUA) to COVID-19 vaccines and drugs subject to certain conditions.
With Taskforce Edward, COVID-19 vaccines that will be approved will be given Certificate of Product Registration (CPR), the FDA said.
These vaccines will then be made available in FDA-licensed drug establishments, it added.
FDA will create specialized unit of experts “to further purpose and objectives of Taskforce Edward.”
“This initiative will help current administration to shift its focus from COVID-19 crisis management to more robust recovery of national economy,” the FDA said.
Zacate encouraged pharmaceutical firms to apply for issuance of CPR or market authorization for their COVID-19 vaccines.
Only one COVID-19 vaccine with EUA has so far applied for CPR issuance, the FDA said.
The Department of Health (DOH) reported that country experienced an increase in COVID-19 related deaths over past months.
DOH Officer-in-Charge Maria Rosario Vergeire said there was only an average of one death per day last June.
“There is an observed increase in number of deaths over these past months,” Vergeire said.
“Last June, we were averaging one death per day…now, we recorded this July, we averaged eight deaths per day…it was similar on August, we saw nine deaths per day this time,,” she added.
Vergeire, based on their July 1 to August 14 data, said that at least 63% of these fatalities were those who were unvaccinated.
The acting DOH chief thus encouraged public to get inoculated against viral disease to prevent severe infection.
“We want to remind our fellow Filipinos that there was higher probability that they may get severe infection and die if they don’t get vaccinated,” Vergeire said.
The DOH OIC said at least 72.3 million Filipinos were fully vaccinated against COVID-19 as of August 18.
Around 6.8 million senior citizens were inoculated, while more than 9.8 million adolescents along with 4.5 million children were fully vaccinated, according to Vergeire.
She said more than 17.3 million individuals received their first booster dose, and more than 1.9 million have received their second dose.
Meanwhile, the Philippines on Friday reported 3,748 new COVID-19 cases, bringing nationwide caseload to 3,848,449.
The Philippines remains at “low risk” classification for COVID-19 with all islands except Mindanao showing plateau case trend, DOH said.
At the press briefing, Vergeire said country remains at low risk case classification with an average daily attack rate (ADAR) of 3.53 cases per 100,000 population.
Meanwhile, the National Capital Region (NCR) and Cordillera Administrative Region (CAR) are still at “moderate risk” with ADAR of 8.83 and 8.54 per 100,000 population, respectively.
ADAR pertains to the incidence showing average number of new cases in period per 100,000 people.
Vergeire said there were 26,302 new cases reported from August 12 to 18.
“The steady increase in cases seen since May is now gradually declining. ..w are averaging 3,757 cases per day, which is 6% lower than previous week, region of Mindanao recorded more than 400 cases per day and is still showing incremental increases in recent days. rest of areas are showing a plateau, ” she said.
The national positivity rate also dropped to 16.7% from 18.5% last week, according to Vergeire.
The positivity rate refers to percentage of people who were found positive for COVID-19 among total number of individuals tested.
Vergeire, however, said national intensive care units (ICU) and severe or critical admissions remain on an uptrend.
She also reported that ICU admissions is currently almost twice of occupancies at the start of July 2022.
The DOH OIC said at least 72.3 million Filipinos have been fully vaccinated against COVID-19 as of August 18.
Around 6.8 million senior citizens were already inoculated, while more than 9.8 million adolescents along with 4.5 million children were fully vaccinated, according to Vergeire.
She said more than 17.3 million individuals have received their first booster dose and more than 1.9 million have received their second dose.
For PinasLakas campaign, Vergeire reported 21,073 senior citizens were vaccinated out of 1.7 million target.
Meanwhile, 1,729,547 individuals have received their first booster dose out of 23 million target.
Vergeire earlier said campaign dubbed “PinasLakas” aims to give booster shots to 23.8 million Filipinos within first 100 days of Marcos administration.
To date, DOH said more than 18,900 “PinasLakas” vaccination sites have been launched all over the country.
Free, safe, and effective vaccines are made available in these areas including markets, schools, workplaces, terminals, places of worship, and mobile vaccination sites, among others.
The weekly COVID-19 positivity rate of the National Capital Region has decreased to 15.3%, independent monitoring group OCTA Research said.
In tweet, OCTA fellow Guido David said region’s positivity rate decreased to 15.3% as of August 17 from 17.2% on August 10.
The positivity rate again refers to percentage of people who were found positive for COVID-19 among total number of individuals tested.
According to David, the one-week growth rate of the region was also at -8%.
Meanwhile, reproduction number or number of people infected by one case was at 1.01. A reproduction number that is below 1 indicates transmission of virus is slowing down.
Despite this, healthcare utilization rate in NCR rose to 40% from 36% while ICU occupancy rate also increased to 36% from 33%.
On Thursday, David said the number of COVID-19 infections in region is on downward trend. He said NCR remains at moderate risk for COVID-19.
The Philippines logged on Thursday a total of 3,844,708 confirmed cases, of which 36,115 are active.
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