THE Food and Drug Administration (FDA) on Monday said it is already reviewing the application for emergency use authorization (EUA) of Janssen Pharmaceuticals for its single-dose Covid-19 vaccine.
This development was welcomed by the Department of Science and Technology (DOST). “One good thing is that Janssen Pharmaceuticals did clinical trials in the Philippines, the results of which only the vaccine developing company can announce,” the DOST said.
The DOST added that more vaccines with EUA approved by the FDA “means more vaccines can enter the country, adding to the adequacy of supply.”
“The DOST is involved in vaccine evaluation prior to clinical trials where our FDA is also the approving authority, particularly through DOST’s Vaccine Expert Panel [VEP],” the DOST added.
The FDA can also tap the services of the VEP in processing EUA applications.
Covid treatments
Meanwhile, the Department of Health (DOH) and the FDA have clarified the claims on the approval of potential Covid-19 treatments.
The Lianhua Qingwen, a prescription medicine approved by FDA in the Philippines, is “not” registered as a Covid-19 medication, DOH said.
“Moreover, the role of the FDA, as per Republic Act [RA] 3720, is to license, monitor, and regulate medicines like Lianhua Qingwen for the safety of Filipinos. Any food or medicinal products not registered in the Philippines should not be sold and are subject to seizure or confiscation hence the FDA issued Advisory 2020-767 before the registration of Lianhua Qingwen,” the DOH said.
On August 7, 2020 Lianhua Qingwen was able to acquire FDA registration but for purposes of being used as a traditional herbal product that helps remove “heat-toxin invasion of the lungs, including symptoms such as fever, aversion to cold, muscle soreness, stuffy and runny nose.”
“Additionally, the use of Lianhua Qingwen is only allowed with a doctor’s prescription.”
Ivermectin
All current Ivermectin products registered in the country, on the other hand, are for “veterinary use” and are only allowed for the treatment of internal and external parasites as well as prevention of heartworm disease in animals hence the issuance of FDA Advisory 2021-0526.
The FDA is currently processing an application filed on March 31 for product registration from concerned parties.
Moreover, studies from The Philippine Covid-19 Living CPG Reviewers of a systematic review of six randomized controlled trials showed that:
1.Ivermectin did not significantly reduce the risk of mortality among patients with mild to severe Covid-19 cases;
2. Ivermectin was not associated with a definite benefit of other clinically important outcomes such as clinical improvement at Day 6-10, clinical deterioration, and need for mechanical ventilation;
3. Ivermectin did not significantly reduce the duration of hospitalization and the time to resolution of symptoms; and
4. The rate of hospitalization discharge did not differ significantly between the Ivermectin group and the placebo group.
Based on the current evidence from randomized controlled trials, the DOH agreed with the Covid-19 Living CPG Reviewers and does not recommend the use of Ivermectin for the treatment of Covid-19.
“Moreover, Dr. Rabindra Abeyasinghe, World Health Organization [WHO] Representative to the Philippines, has stated that there is no evidence that supports the use of Ivermectin to treat Covid-19, even as a preventive measure. The use of ivermectin for Covid-19 has to be evaluated through clinical trials.”
The DOH and FDA said they are open to allowing pharmacies for compounding Ivermectin.
Image credits: Johnson & Johnson via AP