VERA FILES FACT CHECK: Pinoy Ako Blog WRONGLY claims WHO, EU and US all ‘trust’ Dengvaxia

Read this fact check in Filipino

Contrary to claims made by Pinoy Ako Blog author Jover Laurio, not all three international bodies - the World Health Organization (WHO), European Union (EU) and the United States (US) - “trust” the dengue vaccine Dengvaxia.

So far, only the EU endorsed it.

STATEMENT

On Feb. 9, three days after the Department of Health declared a measles outbreak in parts of Luzon and Visayas, Laurio re-shared on her Facebook page a November 2018 blog post where she painted President Rodrigo Duterte as mastermind for the murder cases filed against the previous administration’s health officials in connection to the Dengvaxia controversy.

She wrote:

Marami na ang nagtitiwala sa Dengvaxia tulad ng World Health Organization, European Union at US Food and Drug Administration. (There are many organizations that now trust Dengvaxia like the World Health Organization, European Union and the US Food and Drug Administration.)”

Source: Pinoy Ako Blog, “Si Aling Persing Nadulas, Sinabi Kung Sino Ang May Utos Sa Kanya,” Nov. 16, 2018

Following the statement was a screengrab of an October 2018 story by website precisionvaccinations.com, headlined, “Dengvaxia Dengue Vaccine Endorsed by EU Committee.” Precisionvaccinations.com claims to publish “research-based vaccine news.”

Laurio first published the blog post Nov. 16 amid court and congressional hearings on cases filed against former Health Secretary Janette Garin and several others, claiming Dengvaxia caused the deaths of several children under the government’s immunization program.

FACT

Of the three entities, only the EU has actually endorsed Dengvaxia. WHO has simply issued recommendations for countries deciding to use it, while the US is still assessing the vaccine’s “safety and efficacy.”

About a month before Laurio published the blog post, Dengvaxia maker Sanofi Pasteur Inc. announced that the United States Food and Drug Administration (US FDA) granted them a “priority review” for the vaccine’s biologics license. US FDA’s calendar of hearings currently shows a review is set for March 7:

“On March 7, 2019, under Topic III, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur.”

Source: US FDA website

On the other hand, the WHO in its latest position paper on Dengvaxia published last September said it recognizes the “efficacy and safety” of the vaccine for people who have already had dengue virus infection but that “it increases the risk of severe dengue” for those who have not.

In July 2016, WHO merely came out with a list of “considerations” for countries deciding to use the vaccine, given the available facts on hand. The WHO Western Pacific office reiterated this in December 2017, amidst the senate hearings on Dengvaxia’s procurement:

“The WHO position paper did not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs. Rather, WHO outlined a series of considerations national governments should take into account in deciding whether to introduce the vaccine, based on a review of available data at the time, along with possible risks.”

Source: WHO Western Pacific Region website, “Dengue vaccine,” Dec. 5, 2017.

Of the three, it is only the EU that has categorically approved the use of Dengvaxia.

The European Medicines Agency (EMA), responsible for evaluation, supervision and safety monitoring of medicines in the EU, authorized the use of Dengvaxia last Dec. 12; Laurio’s screencap of precisionvaccinations.com’s story was about EMA’s Committee for Medicinal Products for Human Use recommending the vaccine for authorization in October 2018.

EMA follows similar restrictions set by WHO on who may receive the vaccine, determining that Dengvaxia’s benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic. Its information page on Dengvaxia reads:

“Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic. Endemic areas are areas where the disease occurs regularly throughout the year.”

Source: EMA website


Sources

European Medicines Agency, “Dengvaxia.”

Sanofi Pasteur website, “FDA grants priority review for Sanofi's dengue vaccine candidate,” Oct. 30, 2018.

US FDA, “March 6 - 7, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement”.

WHO, “Dengue vaccines: WHO position - July 2016,” p. 361, July 29, 2016.

WHO, “Dengue vaccines: WHO position - September 2018,” p. 474, Sept. 7, 2018.

WHO Western Pacific Region, “Dengue vaccine,” Dec. 5, 2017.

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