FDA warns: Nasal spray products are not substitutes for medicines, vaccines

Marje Pelayo   •   September 13, 2021   •   363

MANILA, Philippines — The Food and Drug Administration (FDA) has cautioned the public on the claims of nasal spray products authorized in the Philippines.

In an advisory dated September 10, the agency noted that “these nasal spray products have been authorized as medical devices which are intended for short-term use in the nasal cavity and serves as mechanical barrier from particulates. These are sprays that coat the nasal mucosa with substances that have a non-specific effect against pathogens.”

The FDA explained that these nasal spray products “do not have active pharmaceutical ingredients that directly treat, eliminate or prevent diseases.”

Therefore, the agency reminded consumers that these products “should not be used as substitutes to medicines and vaccines to prevent or treat SARS-CoV-2 Infection or COVID-19.”

The FDA encourages the public to be vigilant in using these products claiming prevention or treatment of COVID-19.

 

DOH, ready for pilot vaccination of minors vs COVID-19 set on Oct. 15

Maris Federez   •   October 12, 2021

MANILA, Philippines — The Department of Health (DOH) is all set for the pilot vaccination of children 12 to 17 years old on Friday, October 15.

The DOH said eight hospitals in Metro Manila will be used as pediatric vaccination sites, as follows:

  • Philippine Children’s Medical Center
  • National Children’s Hospital
  • Philippine Heart Center
  • Pasig City Children’s Hospital
  • Fe Del Mundo Medical Center
  • Philippine General Hospital
  • Makati Medical Center
  • Luke’s Medical Center (Taguig)

Children with comorbidity will be given priority in the vaccination drive.

The DOH said only Pfizer and Moderna anti-COVID-19 vaccines will be used in the pilot vaccination as they are the only ones that have been granted emergency use authorization (EUA) for minors by the FDA.

The health department said it will be closely monitoring the vaccination that will be using Moderna vaccines following reports of adverse effects among children that have received the vaccine in several European countries.

These children were reported to have developed myocarditis or inflammation and damage of the heart muscle, resulting in shortness of breath, chest pains, decreased ability to exercise, and an irregular heartbeat.

The DOH spokesperson Usec Maria Rosario Vergeire, however, gave the assurance that such are very rare cases.

“Kapag tiningnan po natin ang ating datos, even internationally, makikita ho natin, of cases of this type of adverse reaction, iyong myocarditis is just less than 1 in a million. So ibig sabihin, it’s very rare,” Vergeire said. —/mbmf

No urgent need for booster shots yet — FDA

Maris Federez   •   October 12, 2021

MANILA, Philippines — The Food and Drug Administration (FDA) on Tuesday said it does not see any urgent need to push for COVID-19 vaccine booster shots.

The FDA said the number of breakthrough infections among those who are already fully vaccinated is still low to consider the administration of booster shots.

“Meron po tayong naireport from the general population na 516 cases or .0025% out of 23 million fully vaccinated individuals which is a very low number,” said FDA director-general Usec. Eric Domingo.

Domingo stressed that they have not yet received reports of diminishing vaccine efficacy after five months of getting inoculated.

“Hindi naman po tumataas ang people getting breakthrough infections dito sa Sinovac. Ibig sabihin, at this time, wala pa pong pangangailangan na magbigay ng booster dahil hindi pa talaga tayo nakakakita pa ng waning effect ng vaccines,” Domingo added.

The Department of Health has also said earlier that there is still no complete evidence that will lead to a decision to administer booster shots. —/mbmf (from the report of UNTV Correspondent Nel Maribojoc)

FDA warns public against fake COVID-19 vaccines sold online

Robie de Guzman   •   September 30, 2021

 

MANILA, Philippines – The Philippine Food and Drug Administration (FDA) on Thursday warned the public against buying COVID-19 vaccine brands allegedly being sold on social media and other online selling platforms.

In an advisory, the FDA said that COVID-19 vaccine brands such as AstraZeneca, Pfizer, and Moderna are allegedly being offered online.

But the agency said the scheme is just a “scam” to attract those who prefer the said brands.

“The public is advised that this is a scam which uses online platforms and social media to attract buyers specially those who have preference on the brand of vaccines specifically our countrymen who work abroad (OFWs),” it said.

The FDA said that scammers involved in this scheme are offering the supposed vaccine brands in a promo deal like buy 2 take 1 deal.

“Once you place your order to the online selling platform, the seller will send a chat message and will give his private contact numbers usually Viber, WeChat, or WhatsApp,” the agency said.

“Payment will be requested to be settled thru Gcash or bank transfer prior to the arrangement of delivery. After the payment, another person/number will send a message asking for courier or delivery fee. When the delivery fee has been paid, another person will send a message asking for the payment of insurance fee. No vaccine product will be delivered even when all payments have been settled,” it added.

The FDA reminded that public that COVID-19 vaccines currently available can only be used under emergency authorization and are not for sale. These are also strictly administered and distributed by national healthcare regulators.

The agency reiterated its call to remain vigilant against counterfeit drugs.

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