Nagpaliwanag ang Department of Health (DOH) matapos alisin sa ilalim ng nakabinbin pang Bayanihan 2 bill ang ikaapat na phase ng clinical trial para sa mga bakuna at gamot ng COVID-19.
Ayon sa DOH, malaki ang naging epekto nang hindi na pagsali sa post-marketing surveillance, sa pagkontrol ng pagkalat ng mga naunang pandemya.
“Accelerated clinical trials and regulatory approvals in response to threats such as Ebola and Meningitis contributed to mitigating the spread of Ebola and decline in the incidence of Meningitis in the sub-Saharan belt.”
Malaking tulong daw ito dahil mas mapapadali ang responde ng bansa sa pandemic, pagdating sa usapin ng vaccine distribution.
Kasama ng DOH na nag-rekomenda ang Food and Drug Administration, Philippine Medical Association at Health Technology Assessment Council (HTAC).
“This recommendation is also not without historical precedent.”
Sa ilalim ng post-marketing surveillance, mahigpit na babantayan kung epektibo at ligtas ang bakuna o gamot kapag ibinahagi na ito sa maraming tao.
Tiniyak ng DOH na naka-ayon sa Section 34 ng Univeral Healthcare Act ang safeguards sa pagpapatupad ng vaccination program sa COVID-19.
“This is in addition to the medication or vaccine being recommended and approved by the World Health Organization and/or other internationally recognized health agencies:
- Conduct of safety and effectiveness surveillance following WHO
recommendations; - A database of recipients of the drugs/vaccines to include the following information
a. basic sociodemographic characteristics
b. place of residence/contact information for follow-up and assessment of
outcomes of interest including adverse events
c. scanned copy of informed consent forms - A transparent and effective risk communication on the benefits and risks of interventions against COVID-19;
- Informed consent and assent to recipients of drugs, vaccines, and other interventions for COVID 19; and
- Conduct of a pilot implementation and community engagement activities before mass roll out.”
Una nang sinabi ni Health Sec. Francisco Duque na kahit siya ay may agam-agam na irekomenda ang pagtanggal sa Phase 4 ng trials.
Ayon sa FDA, hanggang ngayon ay wala pa silang natatanggap na impormasyon ukol sa resulta ng Phase 1 and 2 clinical trials ng Sputnik V mula Russia, na siyang target ng pamahalaan na magkaroon ng trial dito sa bansa.
