Recent weeks have seen two major developments which will affect all of us. The first being the Food and Drug Administration (FDA) approval of the Pfizer-BioNTech Covid-19 vaccine for people aged 16 and older, and the second being the emergency use authorisation (EUA) of both mRNA vaccines for booster doses for immunocompromised people. The FDA along with the Centers for Disease Control and Prevention (CDC) is also laying the groundwork for the booster doses for the entire population for all the three vaccines in the US starting in the fall.
On the surface, a full approval may not sound like a big deal—I mean, most of us already got the doses and nothing crazy happened right? There is a huge difference though. The EUA is the FDA essentially telling you that the vaccine may be effective in preventing Covid-19, the benefits outweigh the risks and that there are no available alternatives. In contrast, a full FDA approval is the FDA telling you that there is substantial effectiveness and safety, and this is the strongest endorsement of the FDA.
The EUA is not a shortcut but the FDA trying to get the product into a population during a health crisis, with the data available at that point of time. An EUA for a product can be terminated, if further data do not meet the efficacy and safety. A full FDA approval is the accumulation of more data during the EUA process, contributing to a more robust scientific conclusion. A lot of my patients have cited lack of full approval as a reason for not getting vaccinated. This should help them and you, the vaccinated, to know you made the right choice. Insurance companies do not cover EUA products. In the case of Covid-19, the government is funding the vaccination drive. A full FDA approval can also lead to some mandates, with the defence department mandating all service members are required to be vaccinated. Moderna has submitted their data for full FDA approval, which is pending.
The story of the Covid-19 pandemic has been two steps forward and one step back. We thought we were through the worst, with the vaccine release. Life was back to normal with lifting of restrictions in the spring, and now we are back to square one. The delta variant has been ripping through the unvaccinated. Close to 90 per cent of the ICU admissions in my hospital are the unvaccinated. This goes along with data released from the CDC, which shows the unvaccinated being 29 times more likely to be hospitalised than the vaccinated. There is another concerning data point though, and that is the breakthrough infections in the vaccinated by the delta variant, with the efficacy waning after six months. The good news is a booster shot that boosts antibodies substantially, between three and eight-fold, and provides added protection against the delta variant. This is the basis for the booster recommendation. How long these antibodies last is anyone’s guess and just to make sure we do not get too comfortable, most scientists believe another mutation is probably around the corner.
The booster dose recommendation has already generated a lot of discussion about vaccine equality. The World Health Organization has warned against a broad rollout of a booster dose, given that many high-risk people worldwide are yet to get a single dose. They cite the lack of broad population data with booster doses and point to the fact that there is still protection against severe disease and hospitalisation (up to 90 per cent) with the two-dose regime. India has at least one dose given to half the population, and in Africa less than three per cent of the population has been vaccinated. The booster requirement will need another billion doses, which will take away from a vulnerable poorer population. Israel has already commenced its booster programme, with the US and most European nations expected to follow in the coming months.
The pandemic has brought out the best and the worst in us. The worst being the politicisation of medicine and the social media derision of certain population groups. I have read social media posts and health care professionals citing lack of empathy for those who have refused vaccines and contracted the disease. If we start judging people for their choices, the list will be never ending. The smoker with heart disease, the diabetic who does not exercise: you get the gist. Some of our premier medical journals have written scathing editorials on administrations and their politics. I believe we should stick to medicine and data with regard to medical care. There is a never-ending stream of news and TV already covering politics. The net result is suspicion of all data from half the population, making the life of the physician in the trenches more difficult. It is easy to pontificate in editorials, but losing a sick patient and spending time with the family is a whole different game—“because we are also what we have lost”.