I was happy that the FDA focused on the scientific evidence and nothing else when it submitted its recommendations to the government. In contrast to vaccines such as Pfizer and AstraZeneca, the Phase III trial results of Sinovac have not yet been released, although data might have been made available to lead the FDA to decide that the vaccine was all right for the healthy population aged 18–59, but not for healthcare workers in contact with COVID-19 patients, seniors, or people with comorbidities.
While AstraZeneca had its dosing issues, Sinovac, on the other hand was noted to have two different lots being studied across their trials. This was a manufacturing issue, which is already one reason for doubt.
When most of the PGH staff signed to be vaccinated, they were expecting that the vaccine administered would be Pfizer, and not Sinovac. The staff were trained to handle the requirements of the vaccine, and it was where the 94% of the willingness came from. PGH spokesman Del Rosario himself admitted: “And thirdly, I have to be honest, some say that it’s because…. they already know the brand of the vaccine that we will be given,” Del Rosario said. “When they learned that it’s going to be Pfizer, then the confidence went up.” PGH chairperson Gab Legazpi also corroborated this claim: “Ang aming preregistration, nagpakitang 94% ay may consent for vaccination. Pero dapat maging tapat ako: nung kinuha namin ang consent nila, Pfizer vaccine ang aming pinaghahandaan,” said Legaspi. (94% provided their consent in our preregistration. But I must be honest: when we obtained their consent, we were preparing for the Pfizer vaccine.)
The confidence of the PGH staff must have gone up when real world data of Pfizer’s efficacy actually corresponded to its laboratory results: it was 94% effective, as Israel had found. However, they were blindsided by the declaration that Sinovac, and not the Pfizer vaccine, was to be administered to them.
To any health care worker who respects science, there always must be a risk-benefit analysis. The question, to me, is: is it worth it taking a risk for a vaccine without definitive data? Because I’m someone who tends to err on the side of safety, my answer is no. I’m not going to go against the FDA’s recommendations. Other people may have different answers, but that’s up to your conscience — I’m sticking to the science with this one.
In Dr. Domingo’s press-release, he noted that while there were no specific safety concerns, “it must be noted that this only reflects limited follow-up and more adverse effects may emerge, and that’s why close surveillance and monitoring is needed after immunization.”
One of the senior members of the Philippine College of Physicians also noted that the six-month efficacy of Sinovac has not yet been established. In other words, we have no solid foundation of data to grasp: it’s like taking a jump out of a plane without any certainty that the parachute will open.
Because of this, I think that data transparency is definitively important when choosing to get a vaccine, and it is what Sinovac doesn’t possess for the time being. When the union of the PGH staff expressed their disdain, I understood, because the evidence as regards its efficacy in health care workers is unremarkable. Further, there hasn’t been definitive data regarding its Phase III trials released yet, and the vaccine isn’t yet even listed in WHO’s Emergency Use Listing (the vaccines included are AstraZeneca, Pfizer, and Serum Institute of India’s COVIshield). Sinovac hasn’t even submitted its dossier for review.
To me, it’s not even about waiting for the best vaccine. Simply put, the FDA simply followed what evidence was there, and I’ll defer to them because it’s what the science shows. Even doctors who work in PGH mostly have the same sentiments (under condition of anonymity, I have interviewed a few of them and they share the same disdain that most of the PGH staff have for Sinovac).
ADDENDA: A day after this article was published, the PGH Physicians’ Association came out with a statement that was against the vaccine roll-out. 95% of the doctors disapproved of the Sinovac vaccine.