LGUs start Janssen vaccine rollout

Maris Federez   •   July 21, 2021   •   197

MANILA, Philippines — Several local government units in the National Capital Region (NCR) on Wednesday (July 21) started using Johnson and Johnson’s Janssen COVID-19 vaccines in their inoculation rollout.

Target recipients for the rollout using the vaccine doses are those belonging to categories 2 and 3 priority groups or the senior citizens and persons with comorbidity.

Local government executives said the use of the American-made single-dose vaccine will be a big help in hiking up the number of fully vaccinated individuals.

The City of San Juan was allocated with 2,800 doses of Janssen COVID-19 vaccine which do not require extremely low temperature in handling and storing.

Mayor Francis Zamora said 600 senior citizens and persons with disabilities were serviced by the local government using Janssen vaccine.

“Hindi po kumplikado ang handling. Once you bring it out you have six hours to vaccinate it. Each vial has five doses. Very simple ang handling niya. Very convenient sapagkat kahit yung mga vaccinator natin imbis na dalawang beses babakunahan yung mga mamamayan namin isang beses na lang. It makes life easier for everyone,” he said.

Caloocan City has also started its vaccination rollout using Janssen vaccine.

The city received 10,300 doses of the vaccine which will be distributed in the barangays.

However, due to the inclement weather, only a few availed of the vaccination services.

Michelle Timple, nurse-in-charge in one of the city’s barangays, also said that a large number of senior citizens has already been inoculated in past rollouts.

“Ever since naman madami-dami na rin kami nabigyan na senior since noong Astra. Sinovac, marami na rin po kaya siguro yung ngayon talaga, siguro yung huli nang magdesisyon, siguro mas anuhin na nila lalo na one dose,” she said.

Dr. Joyce Sollivan, the vaccination site’s assigned physician underscored the advantage of using the Johnson and Johnson vaccine.

“Advantage talaga ito sa mga senior citizen kasi, unang-una, single shot lang siya. Hindi na sila mahihirapan na pupunta rito para pipila ulit. At syempre pag nabigyan sila ng bakuna malaki talaga ang porsiyento na maprotektahan sila against sa COVID-19 virus,” said Sollivan.

Aside from Metro Manila, the government has also allocated and distributed the Janssen vaccine supply in  different parts of the country, such as Lapu-Lapu in Cebu, Panay Province, Cagayan De Oro City, and the Bangsamoro Autonomous Region of Muslim Mindanao (BARMM). —/mbmf (from the report of Correspondent Marvin Calas)

EUA application for Johnson & Johnson’s COVID-19 vaccine still under evaluation – FDA

Robie de Guzman   •   April 14, 2021

MANILA, Philippines – The emergency use authorization (EUA) application submitted by Johnson & Johnson for its pharmaceutical arm, Janssen’s COVID-19 vaccine is still under evaluation, the Food and Drug Administration (FDA) said Wednesday.

During a televised press briefing, FDA director-general Eric Domingo said the agency is looking into reports of rare blood clotting cases linked to Janssen vaccine in other countries.

“Ito kasing Janssen na bakuna very similar siya sa AstraZeneca, itong mga adenoviral vector vaccines. At ito nga ang nakikita na possible na very rare cases of blood clotting. So, kung matapos naman po ang evaluation nito at magkaroon ng recommendation of course, it will probably have recommendations din on how to guide vaccinators at iyong vaccines to watch out for such events at kung anong gagawin kung may naramdaman sila,” he said.

Domingo added that clinical trials using Janssen COVID-19 vaccine are still ongoing in the Philippines.

He said the FDA is carefully reviewing reports on its benefits as well as its health risks on a vaccine recipient.

“Pumasa rin naman siya sa US at saka sa WHO (World Health Organization), ibig sabihin, the benefit of using the vaccine definitely mas matimbang, outweighs the harm,” he said.

“Kaya naman po inaaral naman din natin kapag ganito, kina-calibrate din natin para kapag gagamitin siya ay nakahanda naman tayo kung paano ang tamang guidelines,” he added.  RRD (with details from Correspondent Aiko Miguel)

FDA OKs clinical trial application for Janssen COVID-19 vaccine

Robie de Guzman   •   December 29, 2020

MANILA, Philippines – The application for clinical trial of Janssen COVID-19 vaccine has been approved, the country’s Food and Drug Administration (FDA) announced Tuesday.

“We already approved one. Ito po ‘yung clinical trial ng Janssen. This has been given the go signal by the FDA,” FDA director general Eric Domingo said during a virtual forum with the Department of Health.

“Baka they will start the clinical trial after ng New Year,” he added.

Janssen COVID-19 vaccine was developed by Johnson & Johnson.

Domingo said the applications of two other vaccine developers are being evaluated by the FDA – Clover Biopharmaceuticals and Sinovac, which are both from China.

The FDA earlier expressed hopes to issue an emergency use authorization by January for Pfizer’s COVID-19 vaccine. – RRD (with details from Correspondent Aiko Miguel)

Evidence on talc cancer risk differs for jurors, researchers

admin   •   February 25, 2016

A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York, February 24, 2016. REUTERS/MIKE SEGAR/ILLUSTRATION

A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York, February 24, 2016.
REUTERS/MIKE SEGAR/ILLUSTRATION

A U.S. jury verdict linking regular use of Johnson & Johnson talcum powder to a woman’s death from ovarian cancer has spurred new concern from consumers, but scientists say the evidence of real danger is inconclusive at best.

Jurors in St. Louis on Monday ordered Johnson & Johnson to pay $72 million in damages to the family of a woman who had used the company’s talc-based Baby Powder and Shower to Shower for several decades. The company maintains that the safety of cosmetic talc “is supported by decades of scientific evidence.”Talcum powders are made of talc, a mineral comprised of bits of magnesium, silicon and oxygen that absorbs moisture. In its natural form, some talc contains asbestos, a known carcinogen. But all commercial products sold in the United States have been asbestos-free since the 1970s.

Even so, the association stuck, said Dr. Ranit Mishori, an associate professor of family medicine at Georgetown University.

“That initial idea that talcum has some asbestos in it put that on the radar of certain researchers and public health experts years and years ago,” she said.

Scientists have explored various ways talc might cause cancers in different parts of the body.

Most of the concern has focused on whether long-term exposure to talc fibers might cause lung cancer among talc miners, and whether women who routinely applied talcum powder on their genitals had an increased risk of ovarian cancer, according to the American Cancer Society’s website.

Studies in talc miners exposed to talc containing asbestos have been mixed, but there is no increased lung cancer risk from asbestos-free talc products, the group says.

That leaves the question of ovarian cancer.

Experts believe it is possible in theory for talc to reach the ovaries by traveling up the vagina, through the uterus and Fallopian tubes and into the ovaries, where it causes inflammation.

Dr. Adetunji Toriola, a Washington University epidemiologist at Siteman Cancer Center in St. Louis, said such an association is scientifically plausible.

“We know that inflammation increases ovarian cancer risk. We know talcum powder causes inflammation. The question is, does talc cause cancer by causing inflammation in the ovaries?” he said.

Dr. Daniel Cramer, a Harvard University epidemiologist, first reported on a potential link between talc and ovarian cancer in 1982. He has published several studies since, and his work suggests that talc exposure increases the risk of ovarian cancer, a rare disease, by 30 percent overall.

LEVEL OF PROOF

Cramer, a paid consultant for plaintiff attorneys in the trial against J&J, demonstrated that increased risk in case-controlled studies, which compared past talcum use in women who developed ovarian cancer to women who did not.

Experts said these sorts of studies are less rigorous and prone to bias as women struggle to recall how much or how often they used talcum powder. Results from other, similar studies have been mixed. Some showed an association between talc and ovarian cancers, and some did not.

Two studies using a more rigorous design called prospective cohort studies, however, failed to show any association overall between talc use and increased risk of ovarian cancers.

“We know cohort studies provide much more definitive answers,” Toriola said.

In these studies, researchers identify people who are already using a substance in question and follow them over several years, comparing their results to another cohort of people not using the substance in question.

One study published in 2000 in the Journal of the National Cancer Institute, in which Cramer was a co-author, concluded there was “little support for any substantial association between perineal talc use and ovarian cancer risk overall.”

They did, however, show a “modest” increase in serous ovarian cancer, the most common form.

Based on studies such as these, the International Agency for Research on Cancer, part of the World Health Organization, classified the use of talc-based body powder on the genitals as “possibly carcinogenic to humans,” a category that includes other commonly used consumer products such as coffee and aloe vera.

To prove conclusively that talc causes ovarian cancer would require a randomized clinical trial – the gold standard of scientific proof. But that is not possible because of ethical concerns, Cramer said.

Such a trial would need to deliberately expose women to a product thought to cause cancer and wait to see if they developed ovarian cancer at higher rates than women not using the product.

Mishori said she does not believe there is any proof through “rigorously conducted, high-quality studies that there is a causation or even an association” between talc and ovarian cancer.

As a doctor, she is pragmatic, noting that talc-based powder is not a must-have product.

“If you are concerned, just don’t use it,” she said.

(Editing by Matthew Lewis)

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