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COVID-19 Vaccine Approval at PH Possible in April 2021 – FDA
Manila, Philippines – The country’s Food and Drug Administration (FDA) said Friday that approval of a vaccine against the new coronavirus disease could be possible in April 2021.
During a virtual press conference, FDA CEO Eric Domingo said this is “the best case scenario” if clinical trials are completed on time.
“If clinical trials are completed by December or January, and a company submits an application to the FDA, we may have an approved vaccine by April 2021,” he said.
“Talagang yun best scenario, that is, yung three to six months, magiging three months; assuming they will complete all their analyzes and send them immediately to the FDA, ”he added.
In the same briefing, the secretary of the Department of Science and Technology (DOST), Fortunato dela Peña, said that the period of three to six months is the experts’ estimate on the completion of phase III clinical trials for candidate vaccines. .
“When they say 3-6 months, we prefer to use the longest forecast in our estimates. That would indicate that in that period the clinical trials would have ended and they had probably already submitted their application and the results of their trials to the FDA, ”he said.
Dela Peña said the World Health Organization (WHO) is set to publish its list of selected vaccines and protocols in October and that the fastest clinical trials can begin will be in the last quarter of 2020.
“The vaccine trials according to the experts will last from 3 to 6 months. I think the very early forecast we have for the second quarter of 2021 is still the best forecast we can give, “he said.
DOST said the Philippines is currently negotiating with 17 vaccine developers from other countries and six of them have already signed confidentiality disclosure agreements that would allow the results of their previous trials to be shared.
Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.
The FDA previously promised that it would speed up approval procedures, but assured that no steps will be omitted to ensure the health and safety of the public. – RRD (with details of correspondent Aiko Miguel)
DOST Names 13 Hospitals Participating in WHO COVID-19 Vaccine Solidarity Trials
Manila, Philippines – The Department of Science and Technology (DOST) announced on Tuesday that 13 hospitals will participate in the solidarity trials of the World Health Organization (WHO) for possible vaccines against the new coronavirus disease (COVID-19) in the country.
In a statement, DOST Secretary Fortunato dela Peña said that the Interagency Working Group for the Management of Emerging Infectious Diseases (IATF-MEID) adopted the agency’s recommendation for the zoning of solidarity trials for candidate vaccines against COVID-19 that will be carried out this year.
Dela Peña said that vaccine candidates will be tested in eight test zones, involving a total of 13 hospitals.
He identified these facilities as the Philippine General Hospital, the Manila Physicians Hospital, the San Lazaro Hospital, the Philippine Pulmonary Center, the St. Luke’s-Quezon City Medical Center, the Tropical Medicine Research Institute, the Medical Center. from Makati, Medical City and St. Luke’s Medical Center-BGC, Vicente Sotto Memorial Medical Center, Chong Hua Hospital in Cebu City, De La Salle Health Sciences Institute in Cavite and Southern Philippines Medical Center in Davao City.
The WHO solidarity tests will begin in October and are expected to be completed by the second quarter of the following year.
The head of DOST also confirmed that the Philippines agrees with five COVID-19 vaccine developers that they will allow the sharing of clinical trial data.
Solidarity trial of possible COVID-19 vaccines for a duration of 18 months
The solidarity trial of a possible vaccine for the coronavirus disease (COVID-19) will begin in October and will last 18 months, according to the Department of Health (DOH).
“The expected start, although we say it is tentative because things can change, would be the 3rd week of October. The duration of this solidarity vaccine test would be 18 months, ”according to DOH spokesperson Usec. Maria Rosario Vergeire.
The Health official also reported that the total approved budget is P89.1 million and will be financed by the Department of Science and Technology.
He also clarified that the budget is only intended for operating expenses since it will be the manufacturer of the vaccine that supplies the vaccines that will be used in the clinical trial.
The World Health Organization (WHO) is studying 34 possible vaccines: nine are in Phase III, while the remainder are in Phase II of the clinical trial.
The Department of Health reported that 12 of the 34 manufacturers are in negotiations with the Philippines through bilateral agreements.
“By doing this, we also increase our chances that this allocation will come from these manufacturers because we have agreed to have the phase III clinical trial here,” Vergeire said.
Vergeire also said DOH is waiting for a response from manufacturers to sign the Confidential Disclosure Agreement to begin trials in the country.
“All efforts are getting stronger. We can also access vaccines despite the different provisions of our law, “he said. -AAC (with reports from Aiko Miguel)
FDA Warns Against Buying Unregistered Foods, Including Popular Brand Liver Spread
MANILA, Philippines – The Food and Drug Administration (FDA) issued a warning on Wednesday (September 16) against the purchase and consumption of various unregistered foods and food supplements, including a popular liver spread brand.
According to their notice dated August 26 and published only on September 16, the following products do not have a product registration certificate issued and are therefore not registered with the agency:
- Reno brand liver cream
- Food supplement in whitening capsules Miracle White Advance
- Turcumin 100% natural and standardized turmeric curcumin
- Spanish Desa Bangus in Corn Oil
- Samantha’s Dips And Sauce Spanish Sardine Pasta Sauce
“Since these unregistered food products and food supplements have not gone through the FDA evaluation process, the agency cannot guarantee their quality and safety,” the notice said.
The FDA cited the provision of the Food and Drug Administration Act of 2009, which states that “the manufacture, import, export, sale, offer for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of products for health without proper authorization is prohibited. “
The agency also warned establishments not to distribute, advertise or sell such infringing food products until a proper registration certificate is issued.
Otherwise, they could face regulatory penalties.
