FDA asks hospitals to report vaping-related illnesses amid rising cases abroad
Robie de Guzman • September 9, 2019 • 1301
MANILA, Philippines – The Food and Drug Administration (FDA) is calling on hospitals under the Department of Health (DOH) to report any cases of illness or injury related to the use of electronic cigarettes (e-cigarette) and vaping amid rising number of such cases in other countries.
“The FDA requests all DOH-retained hospitals to immediately communicate relevant case reports of injuries and illnesses documented arising from the use of these devices,” the agency said in an advisory.
The FDA said this is in the interest of evidence-based policy development, and in line with the emerging report of electronic cigarette-related injury and illnesses from Europe and North America.
The agency said the use of electronic nicotine and non-nicotine delivery systems (ENDS/ENNDS) are under the purview of the agency based on Republic Act 9711, the FDA said.
“In compliance with the Data Privacy Act of 2012, it is expected that the information provided will be anonymized in as much as they are thorough and extensive,” the agency said.
As of August 27, U.S. health authorities have monitored 215 possible cases of pulmonary illnesses, all patients have reported using e-cigarette products.
According to the USCDC, e-cigarettes can contain harmful or potentially harmful substances, including nicotine, heavy metals such as lead, volatile organic compounds, and cancer-causing chemicals.
Additionally, some e-cigarette products are used to deliver illicit substances, which may be acquired from unknown or unauthorized sources.
“Based on reports from several states, patients have experienced respiratory symptoms (cough, shortness of breath, or chest pain), and some have also experienced gastrointestinal symptoms (nausea, vomiting, or diarrhea) or non-specific constitutional symptoms (fatigue, fever, or weight loss). Symptoms typically develop over a period of days but sometimes can manifest over several weeks,” the advisory stated.
The USCDC have recommended some steps for clinicians, including the reporting of cases of severe pulmonary disease of unclear etiology and history of e-cigarette use within the past 90 days, to help determine the cause of these sicknesses.
The World Health Organization (WHO) earlier said the use of e-cigarettes should be regulated as there is no evidence proving they were a safer alternative to cigarettes, warning that it normalizes smoking and hooks young people.
The number of coronavirus disease 2019 (COVID-19) cases in the country is now at a downward trend, according to the Department of Health (DOH).
DOH Spokesperson Maria Rosario Vergeire said that, for the past six days, the number of new COVID-19 cases that they have been recording has been under 3,000.
“We look at the trends noong ating mga averages per week. Makikita natin bumababa, nakikita natin bumababa tayo ng around 1,000 to 1,200 cases na comparing to the previous (We look at the trends in our average record per week. We see a decline in number around 1,000 to 1,200 cases compared to the previous records),“ she said.
This is also an indication that COVID-19 transmission in the country, especially in the National Capital Region (NCR), has dropped from the danger zone to moderate. From the 81% Critical Care Utilization Rate in the NCR last August, it went down to 60%.
The Critical Care Utilization Rate refers to the availability of ICU beds in COVID-19 wards, ventilator facilities, and other hospital needs for COVID-19 patients.
Health Undersecretary and Treatment Czar Dr. Leopoldo Vega said the decrease in the number of cases can help in recalibrating the strategies and responses of local government units in addressing the pandemic. This includes a boost in contract tracing and isolation of COVID-19 patients.
“Ang malaking bahagi talaga sa pagsugpo ng COVID-19 ay iyong public health measure. At nakikita mo naman lalo na sa Metro Manila na kapag ang LGU ay aggressive sa testing, isolation at tracing ng mga positive sa COVID-19 ay malaki ng pagbabago (The huge part in fighting COVID-19 is public health measure. As you can see, especially in Metro Manila, if an LGU is aggressive in testing, isolation and tracing of COVID-19 positive it makes a huge difference),” he said.
However, the DOH official said there are still areas where COVID-19 cases remain high and that the public should stay vigilant in abiding by the health and safety protocols.
Vergeire also said that despite the decline, the department still does not recommend to ease the quarantine restrictions in the country.
The Inter-Agency Task Force for the Management of Emerging Infectious Diseases should also consider other indicators such as the attack and growth curve before submitting their recommendation. AAC (with reports from Aiko Miguel)
MANILA, Philippines – The country’s Food and Drug Administration (FDA) on Friday said the approval of a vaccine against novel coronavirus disease may be possible in April 2021.
During a virtual press briefing, FDA Director General Eric Domingo said this is “the best case scenario” if clinical trials are completed on schedule.
“If clinical trials are completed by December or January, and a company would file an application with FDA, it’s possible that by April 2021 we will have an approved vaccine,” he said.
“Talagang best case scenario yun, meaning yung three to six months, magiging three months; assuming that they will complete all their analysis and submitted immediately to FDA,” he added.
In the same briefing, Department of Science and Technology (DOST) Secretary Fortunato dela Peña said the time period of three to six months is the experts’ estimate on the completion of Phase III clinical trials for vaccine candidates.
“When they say 3-6 months, we prefer to use the longer forecast in our estimates. That would indicate in that period they would have finished clinical trials and probably already submitted to FDA their application and results of their trials,” he said.
Dela Peña said the World Health Organization (WHO) is set to release its list of selected vaccines and protocols in October and that the fastest that they can start the clinical trials will be in the last quarter of 2020.
“The vaccine trials according to experts will range from 3 to 6 months. I think the very early forecast that we have of second quarter 2021 is still the best forecast we can give,” he said.
The 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 sharing of their earlier trial results.
Among the six vaccine developers are Russia’s Gamaleya Research Institute and China’s Sinovac.
The FDA earlier promised it would expedite the approval procedures but assured that no steps will be skipped to ensure public’s health and safety. – RRD (with details from Correspondent Aiko Miguel)
The Department of Health (DOH) will conduct a nationwide measles and polio supplemental immunization campaign starting October 26.
DOH Secretary Secretary Francisco Duque said there is still a need to prevent possible measles outbreak especially while the country is facing the coronavirus disease (COVID-19) pandemic.
As of August 2020, there are around 3,500 reported measles cases with 36 deaths. Most of the cases are among children under five years old.
The nationwide Measles Rubella-Oral Polio Vaccine Supplemental Immunization campaign will be rolled out in two phases. The DOH will be conducting the campaign for children under five years old which is around 9.4 million children for the measles-rubella vaccine and 6.9 million children for the oral polio vaccine.
“Despite the COVID-19 pandemic, a high-quality immunization campaign is urgently needed to stop measles transmission and possible outbreaks. We encourage parents and caregivers to have their children immunized. The measles vaccine is safe, effective and free,” he said.
The DOH’s immunization campaign is supported by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF). UNICEF Philippines Representative Oyunsaikhan Dendevnoro said there have been immunization challenges brought by the effects of the COVID-19 pandemic.
“We are at an especially challenging time when immunization for children is being threatened. All of us must do our part in ensuring children in our family are immunized, and that we provide the correct information to parents, community members and among our peers,” she said.
Meanwhile, Duque also assured that the health care workers who will participate in the campaign have been trained and will be provided with personal protective equipment.
The Phase 1 of the campaign will be conducted from 26 October to 25 November 2020 in Mindanao Regions, CAR, I, II, IV-B and V. Phase 2 will be conducted in February 2021 in Visayas Regions, NCR, III and IV-A. AAC
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