I have stated in previous columns that there appears to be a global mad rush at COVID-19 vaccination, unwittingly cutting safety corners in the process.
Vaccines, especially these novel formulations for COVID-19, are far from being harmless, and people who may be at risk for potentially serious reactions should not be given the vaccine.
But in the seeming over-enthusiasm to mass-vaccinate, the obvious safety precautions are being overlooked.
Sometimes, one cannot help but ask, “Is the objective really to protect the global population from COVID-19, or is it simply to mass-vaccinate at all costs, for reasons that are still unclear to many?”
Recently, at least two persons developed life-threatening anaphylactic reaction to the Pfizer-BioNTech COVID-19 vaccine, as it was rolled out in Britain.
Anaphylaxis is a severe, potentially life-threatening reaction to food and medicines, especially to vaccines. Fortunately, the two who had the reaction were promptly treated and did not die.
The scenario may have been a lot different if it happened in a mass vaccination campaign in a third-world country, outside of a hospital facility. Patients with anaphylactic reactions can die within a few minutes if not properly treated.
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) has now upgraded precautions to the vaccine because of these two reports of anaphylaxis.
A statement from MHRA head June Raine said: “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.”
It added that having the vaccine is still recommended. “Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks…You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”
Actually, this concern of a possible anaphylactic reaction was apparently already considered in the clinical trials of the Pfizer vaccine. That may have been the reason those with history of severe allergic reactions were excluded from the clinical trials.
The likely culprit for this is the polyethylene glycol, or PEG, in Pfizer’s vaccine. PEG helps stabilize the product and is not a component in other types of vaccines.
With a new compound, especially a vaccine, one would intuitively think that expert regulators would take the routine precaution of excluding those with a history of severe reaction, but it became only a post-reaction precaution after two near-fatal mishaps in the early part of their roll-out.
This highlights the blinding effects of over-enthusiasm. We’ve had a similar bad experience with Dengvaxia. I hope we don’t have to relearn painful lessons with any of these COVID-19 vaccines.
Some experts argue that the risk is much higher if we don’t have the vaccine. I don’t quite agree. In the Philippines, for example, the risk of getting infected with COVID in the next 12 months is likely less than 0.5 percent, or five in 1,000. The risk of dying from COVID-19 is 0.01 percent or one in 10,000.
In the vaccine trials, the rate of reported adverse drug reactions is around 0.6 percent or six in 1,000. And usually, those with significant medical conditions were excluded in the trials. It’s not really a real-world or real-life scenario. So, we may expect more reactions or side effects in a real-world setting.
The two cases of anaphylactic reaction in Britain highlights this gap in the COVID-19 vaccine clinical trials. Because of the accelerated rate at which the trials were conducted, there remain crucial unanswered questions. We’ll only know the answers with the roll-out experiences in other countries.
The governments of the world should make COVID-19 vaccination voluntary and not mandatory. There should be no discrimination against those who choose not to be vaccinated, like not being allowed to travel, or not being employed. This is not really a just and fair exercise of the state’s police power.
Only those who are willing should get the vaccine shots, after being informed of the possible side effects. Yes, there should be informed consent.
There has to be a strict protocol before it’s administered. Identify and exclude patients at risk, even if they want to be vaccinated.
For me, COVID-19 antibody testing must be part of the protocol. It must be done first as a screening test to determine those who can really benefit from the vaccine. If one has antibodies already for COVID-19 either due to a previous infection or exposure, then one may not need the vaccine. He/she should just have his/her antibody titers rechecked after several months to see if they have gone down already.
Until today, I maintain my stand that, weighing the risks of getting vaccinated or not for the next 12 months, we’re still better off with a wait-and-see attitude.