How safe are the COVID-19 vaccines?

"Nothing beats extra care and attention."

With three COVID-19 vaccines and counting (there are at least five other vaccines on the final stages of clinical trials) ready to be rolled out to restart a tired and weary world, the challenge facing most countries now is to ensure the safety of these products if these are to be accepted and widely used. Given our sad experience with Dengvaxia and the natural reaction to new medical products and practices this will surely be a struggle.

Especially so with this one vaccine, which went through uncharted waters and unprecedented ways to be rolled out. Nothing beats extra care and attention if we are to successfully achieve the vaccines’ potentials to stop the disease from further inflicting damage to our battered world.

To be fair, while there was quite a strict timeline to roll out the vaccines, the manufacturers and regulators made sure that the processes were adhered to. In fact, the regulators signed off on the manufacturers’ claim of their products’ 94-95-percent efficacy. Safety, of course, is another matter. Aware of that giddiness, the manufacturers went to some lengths to show the seriousness of their efforts.

In the case of the Pfizer vaccine, for example, the same was was administered to at least 21,999 people with no serious side effects save for a bit of unease for some volunteers similar to the one after the seasonal flu vaccination, but so far no serious side-effects This prompted Pfizer to declare that under the so-called medical “rule of three” dictum, the probability of affecting vaccinated persons is only one out of 10,000. That means if we are going to vaccinate our entire population, only about 10070 will feel some unease after getting injected. We are told that those from Moderna and AstraZeneca/Oxford had essentially the same result – a feeling of unease and, in some cases, mild chilling.

Given those results, the next hurdle will be the manner by which the COVID-19 vaccination program gets to be implemented. There is the issue of dosage: do we give two doses not one and a half or even just one dose to the priority recipients? Then the logistical needs of having the initial 2 million doses into our shores, warehousing and then distributing the same to the priority sectors and areas. Imagining the complex route of making things happen is already a nightmare given our inadequate facilities and resources including trained personnel to man the vaccination chain.

In this regard, it may be well for our vaccine czar, retired General Carlito Galvez, to check the measures being put in place in most advanced countries to see if these are worth replicating in our shores. The US Center for Disease Control (CDC) has issued from fairly doable guidelines for consideration.

As is the US’ and our own established regimen, the first step is to audit the clinical processes employed in the vaccines’ roll out. That is the work of the FDA and the inter-agency vaccination task force which includes personnel not just from the DoH but from the DOST and some academics and medical practitioners. Their positive audit findings will pave the way for the authorization to use the vaccines.

Then comes the vaccine safety monitoring system which partakes essentially of surveillance and calling out, possibly even detention, of those found violating the implementing guidelines. In the United States, the CDC and FDA have come out with extra measures to evaluate COVID-19 safety protocols in real time, using the latest smartphone-based, after-vaccination health checker called VAERS (Vaccine Adverse Event Reporting System) for those vaccinated to check in and advise if they encountered any problems after getting injected. I doubt if we have this system in place. Heck, we don’t even have a working test and trace system.

Then, they have a National Healthcare Safety Network (NHSN) which is an acute care and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or VAERS. The NHSN has a number of sub-systems ranging from the Vaccine Safety Data Link (VSD) which conducts active surveillance and research to help determine possible side effects and three other systems which include a Sentinel Initiative all meant to provide online surveillance and assistance to vaccinated persons as well as medical and claims assistance as needed.

Finally, they have sector-based networks catering to specific segments of the population such as those in active military service, veterans and yes, even tribal nations through the Indian Health Service VAERS. These systems and institutions are apart from those being directly serviced by individual states which have their own systems and funding sources. These have been in place even before the COVID- 19 outbreak and are being enhanced to meet the requirements of this new, invisible enemy. Sadly, we either have nothing in place save for the Jurassic systems we have had for years servicing the usual annual vaccination programs which were almost shot to the ground with that Dengvaxia debacle. In fact, we have to overcome that mishap involving almost a million vaccinated persons mostly children with a fresh education and information effort in time if we are to successfully implement this COVID-19 vaccination initiative.

To be fair, General Galvez and his crew have been busy these past few weeks since President Duterte ordered the initial 2 million doses for the priority sectors. We will soon see how we will play this out; it is to enhance our COVID-19 response measures and the public’s confidence in our ability to transition and restart our lives.

Gaining the trust of our people and, of course, the global community, is going to be a hard climb. It can only be achieved through total transparency, united action and clear, realistic expectations, both during and long after the vaccines have been deployed and their effects accurately monitored and addressed.