ASEAN COVID-19 PANDEMIC: TAIPEI- Sinopharm ‘most unsafe’ vaccine—Taiwan News; FDA wants proof

A Taiwanese online news company said the COVID-19 vaccine of the Chinese company Sinopharm, with a list of 73 possible side effects, is being called the “most unsafe in the world.”A report in Taiwan News on Wednesday quoted a Shanghai-based vaccine expert named Tao Lina, who said Sinopharm’s instruction manual listed 73 side effects or adverse reactions including high blood pressure, loss of vision, and loss of taste. While doctors reportedly joked about the long disclaimer, Tao pointed out that because such side effects are listed on the manual, patients who experience adverse reactions won’t be able to sue the state-owned pharmaceutical firm.Sinopharm is among the COVID-19 vaccine frontrunners. Its vaccine is already in limited use in China, United Arab Emirates and Bahrain.

It also claims to have a 79 percent efficacy rate against COVID-19.Sinopharm’s vaccine was also reportedly used to inoculate members of the Presidential Security Group (PSG), even though it has not obtained local Food and Drug Administration (FDA) approval.The Taiwan News article said Tao works for the Shanghai Center for Disease Control and Prevention (SCDC) and that his post on Weibo, a Chinese microblogging site, was deleted by authorities.The Chinese Embassy has yet to make a comment.MKG Manufacturing Corp., which identifies itself as the distributor of Sinopharm in the Philippines, declined to comment.Asked to comment on the report, FDA Director General Eric Domingo said, “If and when they submit an application for EUA [Emergency Use Authorization], all safety concerns will be closely looked into by our experts.

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As they do for all applications.”Philippine Foundation for Vaccination’s Dr. Lulu Bravo also said it was necessary to look at the scientific data first.“If there is no data, then conclusions cannot be made,” Bravo said.“But safety is always a prime concern. No one will approve an unsafe vaccine,” Bravo said.Bravo also warned against examining scientific data through online media reports because of the proliferation of fake news.Science and Technology Secretary Fortunato dela Pena said the public should trust the country’s drug regulator not to authorize the local use of any vaccine that is unsafe.

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Among the other side effects mentioned in the manual posted on Weibo are pain, swelling, and itching on the vaccination area. The manual also mentioned headache, fever, muscle pain, difficulty breathing, and diarrhea as common “systemic adverse reactions.”Listed as “occasional” effects are anorexia and vomiting while “very rare” effects include asthma, tonsillitis, eye pain, vision loss, earache, high blood pressure, urinary incontinence, and delayed menstruation.

The Department of Science and Technology (DOST), meanwhile, said the Gamaleya Institute from Russia is filing for emergency use authorization (EUA) for their COVID-19 vaccine in the Philippines this week.DOST Undersecretary Rowena Guevarra said Gamelya also withdrew its application for clinical trials in the Philippines because of the EUA application.The country’s vaccine czar, Carlito Galvez, said the government aims to vaccinate between 50 million and 70 million Filipinos—or half the country’s population—within the year.Galvez, the chief implementer of the National Task Force (NTF) against COVID-19, said the country is already in the advanced stages of negotiations with United States’ Novavax, Pfizer, and Johnson & Johnson; United Kingdom’s AstraZeneca; China’s Sinovac Biotech; and Russia’s Gamaleya Research Institute.Galvez said the government will receive fully subsidized doses from the Covax Facility for the first 20 percent of the population or 22 million Filipinos.

The government plans to secure at least 148 million doses of COVID-19 vaccines to cover some 70 million Filipinos, he added.He assured the public that the government has taken scientific evaluations to ensure that safe, effective, and free COVID-19 vaccines will be provided for all Filipinos.He dispelled concerns raised by an independent survey that showed only 25 percent of respondents in Metro Manila are willing to be vaccinated while 28 percent did not want to receive an anti-coronavirus shot. Galvez said no one will be left behind for the inoculation.The DOST said it is looking for 15,000 participants for the World Health Organization’s Solidarity Trial of COVID-19 vaccines, which will start by the end of January or in February.The number of target participants was increased from the initial 4,000 to 15,000 in line with the WHO’s goal of conducting “rapid, community-based enrollment in hotspot areas,” Guevara said.In other developments:* The President has approved a proposal for tripartite agreements with local government units and vaccine manufacturers “to maximize their manpower, expertise, and resources to ensure a coordinated, integrated, and holistic Covid-19 immunization program,” Galvez said Friday.

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Galvez said the tripartite agreement is aimed at providing unified and synchronized efforts among the government, LGUs, and vaccine developers, to ensure the acquisition of sufficient doses of Covid-19 vaccines for the country.* An ex-official of the Philippine Medical Association on Friday came forward to lawyer for the Presidential Security Group (PSG) should lawsuits be filed for its alleged use of smuggled COVID-19 vaccine from China. Leo Olarte, a lawyer and Clean Air Philippines Movement Inc. president, told dzBB Teleradyo that “the act to smuggle and use unregistered COVID-19 vaccine from China might be illegal and a clear violation of our local Food and Drug Administration regulation, but he pointed out there were justifying and exempting circumstances that would keep the soldiers out of jail. Olarte is a former Philippine Medical Association president.*

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Starting Jan. 8, flag carrier Philippine Airlines will not accept foreign travelers from six countries that were later included by the government in its travel restrictions. India, Portugal, Finland, Norway, Jordan and Brazil are now included in the list of countries covered by travel restrictions by the Philippine government. “As a result, PAL will be unable to accept, on our flights to the Philippines, any foreign passengers who originate from the above countries effective 12:01 a.m. Jan. 8 (Philippine Time) until Jan. 15, 2021,” PAL said in a statement.