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Sinovac offered to health workers despite FDA’s warning

MJ Blancaflor



The coronavirus vaccine developed by Chinese firm Sinovac will be offered to local health workers, the Department of Health (DOH) announced Friday, even if the Food and Drug Administration (FDA) has flagged the jab over its perceived “low” efficacy rate among medical personnel.

Health Undersecretary Maria Rosario Vergeire said experts from the National Immunization Technical Advisory Group (NITAG), as well as the health department’s Technical Advisory Group (TAG), ruled that the jab is “safe and efficacious,” especially in preventing severe cases of Covid-19.

Vergeire, along with the members of the two advisory groups, also maintained that their findings do not run contrary to FDA’s provision in Sinovac’s emergency use authorization (EUA).

“We want to emphasize that the prohibition on use for healthcare workers, attending to Covid-19 patients included in the EUA granted for Sinovac is not a contraindication nor a recommendation, born of concern over the vaccine safety. The FDA did not say that the vaccine is prohibited for health care workers,” Vergeire said in a media conference.

“The NITAG and the TAG have deemed it sufficient to recommend the use of the vaccine for healthcare workers as it bears to reiterate that our goal for prioritizing health care workers for vaccination is to reduce morbidity and mortality,” she added.

The FDA has authorized the vaccine for emergency use, but not to health care workers exposed to Covid-19 patients, since it merely yielded a 50.4 percent efficacy rate in a clinical trial in Brazil — barely passing the threshold set by the World Health Organization. The Brazil trial included 12,396 medical workers older than 18.

Separate Phase 3 trials in Indonesia and Turkey found it had an efficacy rate of 65.3 percent and 91.2 percent, respectively. The trials were done in community settings and not among health professionals.

Vergeire, meanwhile, underscored that it is up to health care workers to decide whether they want to get Sinovac’s vaccine and they may opt to wait for another brand.

“Binibigyan po natin ng karapatan ang recipients to have that value judgment para mamili kung gusto po nilang tanggapin ito or kung gusto nilang maghintay ng iba pang bakuna,” she said.

The government expects 600,000 doses of Sinovac’s vaccine, commonly known as CoronaVac, to arrive on Sunday at the Villamor Airbase in Pasay City.

Vergeire said officials are still finalizing the list of hospitals that will receive the first batch of CoronaVac, but healthcare workers in Covid-19 dedicated facilities such as the Philippine General Hospital (PGH) and the Lung Center of the Philippines are prioritized.

Earlier in the day, PGH workers staged a protest outside the facility on Taft Avenue in Manila as they demanded the government provide them with a safe Covid-19 vaccine with a higher efficacy rate than that of Sinovac.

Dr. Gerardo Legaspi, PGH director, previously said that their medical workers are willing to receive any brand of coronavirus jab.

The state-run hospital announced last week that 94 percent of their employees have expressed willingness to receive the vaccine, but Legaspi admitted that they had assumed that Pfizer-BioNTech vaccine would arrive first in their hospital.

The health department is hoping that medical professionals will acquire the vaccines seen to reduce coronavirus transmission as well as severe and fatal cases of Covid-19, said DOH’s Vergeire.

“Sana tanggapin ng ating mga kababayan, especially health care workers, ang bakuna dahil ang objective ng ating goberno ay protektahan ng taumbayan sa sakit,” she said.

In Malacañang, presidential spokesperson Harry Roque expressed confidence that local health care workers would get themselves inoculated to “boost public confidence in our mass vaccination program against the coronavirus.”

Medical frontliners, the elderly, and people with comorbidities are supposed to receive the first Covid-19 vaccines in the country based on the priority list prepared by the government.

President Rodrigo Duterte will join a welcome ceremony of Sinovac vaccines to be shipped via a military aircraft, Roque confirmed to reporters.

The Palace official previously said Duterte wanted to attend the vaccine’s welcoming rites to show his gratitude to China, which donated doses of CoronaVac.

The Philippines is expecting a total of 25 million vaccine doses from Sinovac this year.

The vaccine works by using “killed” viral particles or a traditional technology to expose the body’s immune system to the virus and help it produce antibodies to fight off Sars-Cov-2, the virus which causes Covid-19, without risking a serious disease response.

To develop the vaccine, Sinovac researchers obtained coronavirus samples from patients in China, Britain, Italy, Spain, and Switzerland, then grew large stocks of it in monkeys’ kidney cells.

They doused the viruses with a chemical called beta-propiolactone to make it “inactivated.”

CoronaVac could be distributed to far-flung areas since it only requires 2 degrees Celsius (36 Fahrenheit), a temperature within the existing cold chain system in the country at which flu vaccines are kept.

Its storage requirement is comparable to Oxford-AstraZeneca’s coronavirus vaccine, which is made from a genetically engineered virus.

At least 12 countries have been using CoronaVac, including Singapore, Indonesia, Malaysia, Thailand, Hong Kong, Turkey, Brazil, Chile, Colombia, Mexico, and other Latin American countries.

There were no severe side effects reported with the vaccine.

Helen Yang, general manager of Sinovac’s Hong Kong office, said muscle pain is the only common side effect of the jab “due to the aluminum hydroxide which is adjuvant in the vaccine.”

“So, people just feel muscle pain after getting vaccination but it can go over after a day,” she said in a televised Palace briefing on Wednesday (Philippine time).

“There hasn’t been any fatal impact of relating to use of the vaccine,” Yang added.

Earlier in November, Sinovac’s trials were briefly halted after the reported death of a volunteer, but resumed after it was found to have no links to the vaccine.

The vaccine has been approved for emergency use in high-risk groups in China since July.

Just a few days before February ends, the Philippines has over 571,000 coronavirus cases with deaths at more than 12,000.

The said count remains the second highest in Southeast Asia, and the more infectious Covid-19 variant has been detected in the country along with two other mutations.

The Philippines is lagging in Southeast Asia in terms of vaccination programs as limited global supply and paperwork stalled the shipment of doses.