Controversial dengue vaccine not yet available in the market

admin   •   May 10, 2017   •   3821

MANILA — A drug store defended itself against alleged sale of dengue vaccine which violates an FDA order.

In a statement, the drug store said the dengue vaccine is not yet available in the market, and vaccination services did not push through because of an FDA directive.

The said drug store has also coordinated with the FDA in relation to requirements for selling the anti-dengue vaccine.

The Food and Drug Administration (FDA) has issued a cease and desist order last week against a pharmaceutical company due to unauthorized promotion of dengue vaccine.

The pharmaceutical company said it will not give any statements while a final resolution on the use of the dengue vaccine is yet to be finalized.

However, it said it is ready to cooperate in the FDA’s investigation.

The FDA reminds the public to be cautious in buying medicines or availing of any vaccine services without its approval.

Meanwhile, the health department said free anti-dengue vaccination for grade 4 students will continue.

DOH Secretary Paulyn Ubial said the third dose of the free anti-dengue vaccine program will end in the following months.

“It is still for implementation April to June. So there were areas that completed their vaccination in June. Some expect that the vaccination will continue until June”, said Department of Health Sec. Paulyn Jean Ubial — Aiko Miguel | UNTV News & Rescue

FDA warns of text message offering COVID-19 vaccines at P50K

Maris Federez   •   October 29, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) on Thursday warned the public of a text message that has been circulating and is offering vaccines against coronavirus disease 2019 (COVID-19) in the amount of P50,000.

The text message is in Chinese, saying the said anti-COVID-19 vaccine is available in a clinic located in Makati City.

FDA Director-General Eric Domingo said he has also received the said text message and immediately had the message translated.

“Some of my friends na marunong magbasa ng Chinese ino- offer siya ng P50,000 per dose. Tapos dalawang doses ang ibinibigay. Napakamahal. Kasi talagang tina-target ng WHO dito cost ng bakuna is about $10 or P500 bawa’t isa,” said Domingo.

“Kung anoman itong ina-attempt ibenta na ito, kung fake ito o kung saan man ipinuslit ito, ay pinagsasamantalahan ang mga tao at ang mga willing na magpabakuna ng untested o unregistered,” he added.

Domingo, on the other hand, said that they have conducted an inspection at Centuria Makati Medical on Wednesday and have not seen any trading of the vaccine in the area.

“Iyong sa Centuria wala naman kaming nakitang dahilan na ifile- an sila ng kaso. Pero iyong DOH is also investigating kasi maraming clinic. So tinitingnan lang to make sure na iyong clinics na iyon ay gumagawa ng nararapat lamang sa kanilang lisensya or kung may lisensya sila o wala,” said Domingo.

The FDA reiterated that there is no COVID-19 vaccine that has already been approved to date.

“Huwag po kayong papatol sa ganito […] Kami po mismo ang magsasabi sa publiko kung ano ang registered, kung ano ang allowed, kung ano ang form nito, kung ano ang itsura nito para sigurado sila,” Domingo insisted.

“Tandaan po natin mabibili lang ang mga ito sa licensed din na mga outlet — mga pharmacy, mga botika na talaga pong may lisensya at maaari pong magbenta ng ganitong produkto,” he added.

Authorities are now ascertaining the source of the Chinese text message.

The FDA warns that a facility, establishment or clinic will face cease and desist order once proven that they are selling unregistered vaccines.

Individuals who will be found involved in the said illegal activities will also be slapped with criminal charges. — /mbmf

Duterte wants government-to-government deal for COVID-19 vaccines

Maris Federez   •   October 27, 2020

MANILA, Philippines — President Rodrigo Duterte announced on Tuesday that he is more inclined to having a government-to-government deal in procuring coronavirus disease (COVID-19) vaccines to prevent the risk of corruption.

The chief executive reiterated that the country will not beg other nations for access to vaccines, and that he favors purchasing vaccines from China or Russia. The two countries have submitted their applications to conduct clinical trials for their inoculations in the Philippines.

Hindi kami hihingi (we will not beg), we will pay,” Duterte said in a taped address to the nation aired on Tuesday (Oct. 27).

So maganda sana government to government ang transaction. Walang korapsyon, wala lahat kasi government to government (It would be better for the transaction to be government-to-government. No corruption, no nothing because its government-to-government),” he said.

Duterte also said that he had a meeting with Chinese Ambassador to the Philippines Huang Xilian on the status of their vaccine.

“We had a meeting with Ambassador Huang. He said the vaccine is there. It would be a matter of paano i-distribute (the manner of distribution) and what kind of transaction would it be for them and for us,” he said.

China’s Sinovac Biotech shall be starting the late-stage trials of its vaccine in the Philippines in November after the Food and Drug Administration has completed the evaluation of its application.

The Philippine government is also evaluating Russia’s Gamaleya Research Institute and Johnson & Johnson’s Janssen unit for their application to conduct the Phase 3 trials of their COVID-19 vaccine.

Philippine authorities are also in talks with drugmaker Pfizer Inc. and with Moderna Inc. as potential suppliers.

The government has initially allotted $400 million to buy 40 million doses for 20 million Filipinos, as part of the administration’s plan to have the entire population inoculated.

As of Sunday (Oct. 25), the Philippines recorded 2,223 new coronavirus infections, and 43 more fatalities, bringing the total in the country to 370,028 cases, and 6,977 deaths. —/mbmf

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

Aileen Cerrudo   •   October 23, 2020

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)

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