DOH-FDA receives first report of vape-associated lung injury case in Phl
Maris Federez • November 15, 2019 • 658
MANILA, Philippines – The Department of Health (DOH) on Friday (November 15) announced that it has received an official report on the first case of E-cigarette or Vape-Associated Lung Injury (EVALI) from a private pediatric pulmonologist based in the Visayas.
Based on the DOH information released to the media, the patient is a 16-year old female who had been using e-cigarettes for six months while concurrently consuming combustible cigarettes, referred to as “dual-use.”
It said the patient, who was admitted last October 21, initially presented sudden-onset of severe shortness of breath which required them to administer her with oxygen and be admitted to the ICU.
The report also said the clinical impression was initially considered to be infectious in nature, but after further evaluation, the patient met the case criteria for EVALI based on the guidelines of the US Centers for Disease Control (CDC).
The patient, however, was subsequently discharged after receiving appropriate care from the attending pulmonologist who is now in continuous communication with the DOH regarding the condition of the patient.
Health Undersecretary Rolando Enrique Domingo said, “all e-cigarette users should seek immediate medical help, and ask their doctors for ways to quit these harmful products.”
“No e-cigarette product should be accessible to young children and adolescents, who are uniquely susceptible to the harms of e-cigarettes and nicotine. I urge non-users not to even try e-cigarettes at all,” he added.
MANILA, Philippines – The Department of Health (DOH) announced that the Philippines has received confirmation of its participation in the COVID-19 vaccine financing instrument – COVAX facility – Advance Market Commitment.
The COVAX Facility, an initiative of the World Health Organization (WHO), is a global procurement mechanism which invests in a broad portfolio of promising vaccine candidates to support their research, development, and manufacturing.
This facility was setup to ensure fair and equitable access to COVID-19 vaccines.
“With the country’s participation in the COVAX Facility, the country is set to receive vaccines in the first quarter of this year,” the DOH said in a statement on Wednesday.
As part of the preparations for the COVID-19 vaccine deployment, Health Secretary Francisco Duque III and Vaccine Czar Secretary Carlito Galvez, Jr. on Wednesday visited three cold storage facilities that can potentially be used in the first wave of COVID-19 vaccine roll-out.
The cold chain facilities visited were the First Pioneer Distribution Center of UNILAB located in Biñan City, Laguna, the Research Institute of Tropical Medicine (RITM) in Muntinlupa City, and the Zuellig Pharma Corporation in Parañaque City.
“The inspection was carried out to ensure that the cold chain facilities will meet the storage requirement of vaccines prior to its distribution to identified vaccination sites,” the DOH said.
UNILAB’s cold storage facility has a temperature range of +2 to +8 °C and can store a maximum of five million doses of vaccines.
Meanwhile, Zuellig Pharma reported that its facilities can accommodate pharmaceutical products with temperature requirements ranging between -80°C to +25 °C. Its cold rooms with temperature ranging from +2 to +8 °C can store up to 629 million doses in various warehouses, its -15 to -25 °C walk-in freezers can hold up to 40 million doses, and its 14 ultra-cold freezers with -80 to -70 °C temperature range has the capacity to store up to 6.5 million doses.
“The vaccine cluster, on behalf of the government, is grateful to UNILAB and Zuellig Pharma for partnering with the government in further strengthening the country’s capacity to curb the pandemic. We also express our commitment to ensure continued support for RITM in its preparations to receive vaccines,” Galvez said.
RITM Director Dr. Celia Carlos said that RITM currently has four cold rooms with a +2 to +8 °C temperature range, one -20 °C walk-in freezer, and two borrowed ultra-low temperature freezers with a -70 to -80 °C temperature range. Presently, RITM commits its ultra-low temperature storage facility.
With this, the DOH said that Galvez has recommended the constitution of another team at the RITM exclusively handling the COVID-19 vaccine deployment, adding that a separate team for EPI (Expanded Program of Immunization) vaccines is ideal for an uninterrupted focus and roll-out of both immunization programs.
Duque, on the other hand, noted that aside from cold chain facilities, the vaccine cluster is also in talks with third-party logistics providers to ensure efficiency of the entire supply chain management of COVID-19 vaccines, from the receipt of vaccines from the COVAX Facility to its deployment.
“All of these preparations that we are undertaking are aimed at ensuring that the country is ready to receive, store, and mobilize the COVID-19 vaccines that will come from the COVAX Facility,” Duque said.
MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.
Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.
Vergeire also said that studies need to be done on the matter.
“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.
“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.
The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.
FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.
Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.
“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.
“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)
MANILA, Philippines – The Department of Health (DOH) on Monday clarified that the prices of novel coronavirus disease (COVID-19) vaccine circulating online were indicative market prices based on the rates published by manufacturers and not the negotiated prices with the Philippine government.
In a statement, the DOH said the prices were generated for the purpose of estimating the proposed budget for the procurement of the vaccine.
The department issued the clarification in response to a price list released by a senator during the Senate’s hearing on the government’s COVID-19 vaccination program.
The price list showed that total prices for two doses of Moderna cost P3,904 – P4,504; Sinovac, P3,629.50; Pfizer, P2,379; Gamaleya, P1,220; COVAX Facility, P854; AstraZeneca, P610; and Novavax, P366.
“These are not, in any way, the negotiated prices that the government and the manufacturer agreed on,” it said.
The DOH then urged the public to “trust and respect the process that the country, through vaccine czar Secretary Carlito Galvez, is undertaking to ensure that Filipinos are afforded the best vaccines at the most ideal prices.”
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