Phase 3 clinical trials for CoronaVac to possibly begin in November—FDA

Aileen Cerrudo   •   October 23, 2020   •   194

The Food and Drug Administration (FDA) said the phase 3 clinical trials for Sinovac’s CoronaVac would possibly begin in November, once the Chinese biopharmaceutical company submitted all the necessary documents.

The FDA said they are awaiting three documents from Sinovac to begin phase 3 of the clinical trial.

FDA Director-General Eric Domingo expressed confidence there will be a potential vaccine in the country by next month.

Ang aming timeline is mga two to three weeks. So once ma-complete naman nila ang submission at ma- kompleto nila lahat ng requirements ng FDA at ng Research Ethics Board, then maaari na silang magka-approval in the middle of November (Our timeline is around two to three weeks. So once they completed the submission and the requirements of the FDA and the Research Ethics Board, then there will be an approval by the middle of November), he said.

However, the agency clarified that CoronaVac could still not be administered to Filipinos.

The FDA assures that they will monitor the effect of the CoronaVac if it will be safe to use.

Hindi siya pwedeng dalhin dito at ibenta dito kasi hindi pa natin nakikita at hindi pa subok kung siya ay effective. Kaya hindi po tayo dapat mag- panic at biglang gumamit ng mga ito (It cannot be brought and sold here because we still cannot prove if it is effective. So we should not panic and use it), Domingo said. -AAC (with reports from Aiko Miguel)

Duterte authorizes FDA to issue emergency use of COVID-19 vaccines

Robie de Guzman   •   December 3, 2020

MANILA, Philippines – President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for COVID-19 vaccines and drugs that are expected to be made available in the Philippines next year.

Under Executive Order (EO) No. 121 signed on Dec. 1 and made public by Malacañang on Wednesday, Duterte granted authority to the FDA director general to issue EUA for COVID-19 drugs and vaccines, subject to provided conditions.

The EO stated that an EUA on a COVID-19 vaccine or drug shall be issued and remain valid only when all of the following circumstances are present:

  • Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
  • The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; and
  • There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treat9ing COVID-19

An application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or public health program implementer, the EO read.

The FDA shall then convene a panel of experts on drug and vaccine development to review available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. The panel will then submit its report and recommendations to the FDA director general.

“In evaluating applications for EUA, the FDA director general shall have the power to implement reliance and recognition processes for emergency use of drugs and vaccines,” the order stated.

“For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization), US-CDC, or other internationally recognized and established regulatory authorities,” it added.

An EUA issued pursuant to the order shall be valid within the duration of the declared public health emergency due to COVID-19, and may be revoked or revisited by the FDA director general.

FDA director general Eric Domingo earlier assured they will not compromise public safety with the sped-up process.

The Philippine government is looking to administer the vaccines to at least 70 million Filipinos under an immunization program that may be carried out within three to five years. – RRD (with details from Correspondent Rosalie Coz)

US FDA authorizes first COVID-19 kit for self-testing at home

Robie de Guzman   •   November 18, 2020

The US Food and Drug Administration (FDA) announced it has approved the first novel coronavirus disease (COVID-19) diagnostic test for self-testing at home.

In a statement issued on Tuesday, the US FDA said it has issued an emergency use authorization (EUA) for the COVID-19 All-In-One Test Kit, made by Lucira Health, for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.  

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the US FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Stephen Hahn.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he added.

The FDA said the test works by swirling the self-collected sample swab in a vial that is then placed in the test unit.

“In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” it added.

Individuals with positive results are advised to self-isolate and seek additional care from their health care provider.

While those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

The kit may also be used in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

The test is currently authorized for prescription use only, the FDA said.

FDA warns against purchase, use of certain brands of KN95, surgical masks

Marje Pelayo   •   November 17, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) has warned all healthcare professionals and the general public not to purchase and use medical devices such as protective masks that are not certified by the agency.

In an advisory issued by the Department, these unverified products include the following brands of disposable masks:

Based on the agency’s post-marketing surveillance, the said products were found to lack any product notification certificates from the FDA. 

Thus, the agency cannot assure the safety and quality of these since they have not gone through proper evaluation process.

In addition, the agency warns traders that sale and distribution of unverified products are punishable by law pursuant to Republic Act No. 9711.

All establishments are warned not to sell or advertise these medical device products until they have met regulatory standards. 

According to the Department, it is always best to look for an FDA Notification number on the product label, and check if the product has been notified by using their Embedded Search Feature accessible at www.fda.gov.ph before purchasing such. MNP / Raymund David

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