FDA sees applications for commercial vaccine distribution by yearend

MANILA, Philippines — Pharmaceutical firms might already apply for commercial distribution of coronavirus vaccines in the country as early as the end of this year, the Food and Drug Administration (FDA) said yesterday.

“Personally, I expect the earliest that will apply for certificate of product registration is late this year or early next year,” FDA director-general Eric Domingo told a television interview.

Domingo noted that phase 3 clinical trial must be completed prior to filing of certificate of product registration (CPR) with the FDA.

The FDA has so far granted emergency use authorization (EUA) to seven pharmaceutical companies for the use of their vaccines in the government’s COVID-19 immunization program.

China’s Sinopharm, the jab received by President Duterte, was only granted a compassionate special permit (CSP).

Domingo stressed that a CSP or EUA does not allow manufacturers to make their vaccines commercially available.

Home inoculation

Meanwhile, home vaccination for house-bound persons like bedridden individuals and those physically impaired is being pushed by an administration lawmaker.

“There are many of our people who cannot go out of their home due to sickness, age or physical disability. The IATF (Inter-Agency Task Force for the Management of Emerging Infectious Diseases) and the DOH (Department of Health) could arrange home inoculation for these most vulnerable citizens through local government units,” Rep. Precious Hipolito-Castelo said.

The neophyte Quezon City congresswoman said the target individuals or their relatives could register with their barangays, whose officials could check on their condition.

“Alternatively, barangay officers could seek them out. They could request for volunteer doctors or nurses who could do the vaccination so as not to further burden healthcare workers in LGU immunization centers. The DOH and LGUs could just monitor the home inoculation,” she said.

Castelo said home vaccination would ensure that no one would be left out in the government’s immunization program against the coronavirus disease 2019.

‘Tap unregistered nurses’

Meanwhile, Speaker Lord Allan Velasco wants unregistered nurses tapped as medical frontliners to combat the spread of COVID-19, particularly in hospitals where doctors and nurses are already overwhelmed.

“Since the board exams for nurses have already been postponed, we can actually tap them, or these nursing graduates who are about to take the board exams, and use them temporarily as health workers,” the lone Marinduque congressman suggested.

Velasco said he would make representations with the Professional Regulation Commission (PRC), which administers the board exams for nurses, and the DOH for purposes of “complementary manpower” due to shortage in heath personnel.

He said unregistered nurses can work “under the supervision of a registered nurse or doctor through a special arrangement with the PRC.”

The PRC postponed this year’s first batch of the nursing board exam scheduled on May 30 and 31 upon the request of the Philippine Nursing Association due to the recent surge in COVID-19 cases. The exam was rescheduled to Nov. 21 and 22 this year. – Delon Porcalla