The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee concluded its Thursday meeting by recommending that a coronavirus vaccine developed by Pfizer be granted an emergency use authorization.
Another vaccine, developed by biotech company Moderna, is expected to be authorized soon. Both Pfizer’s and Moderna’s vaccines show 95% efficacy in preventing infections, which means the definitive end of the COVID-19 pandemic may be imminent.
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I, for one, eagerly await the chance to immunize myself—to both protect myself and to prevent myself from being able to contract and transmit the virus any further. And once that injection goes into my arm, I will be asking, “Please, may I have another in 21-28 days, per the dosing protocol?”
But even with impending approval of both vaccines, I—a young healthy individual at very low risk from COVID-19—will have to wait a little longer to get my immunization. Possibly until spring.
This is as it should be. As part of a wise vaccination policy, the initial doses will first go to where they will have the most benefit.
Those over 65 years of age continue to make up a relatively small portion of COVID-19 cases, but a disproportionately large proportion of mortality. Giving them first access to the protection of the coronavirus vaccine will have the greatest and most immediate benefit to the cause of saving lives from this virus.
Understandably, many people I’ve talked to have expressed concern with how fast these vaccines have been produced. But I have great confidence in the vaccines’ safety performance.
The coronavirus vaccine development process was sped up by taking out slack in all of the bureaucratic, nonclinical barriers to drug approval.
As Ed Haislmaier, a senior research fellow at The Heritage Foundation, described it, “Both biomedical companies and federal officials recognized early on that the key to speeding up the effort was to ‘parallel process’ whenever and wherever possible, meaning processes that would normally take place sequentially were pursued simultaneously.”
In other words, Operation Warp Speed—the national initiative to fast-track the development of a coronavirus vaccine—accelerated the development process by cutting the slack while maintaining rigorous safety precautions.
In fact, participation in Operation Warp Speed required manufacturers to enroll at least 30,000 participants in the phase three trial—the final phase of clinical trials before drugs can be given to the public.
Although the phase three trial for Pfizer’s vaccine has not yet concluded, it already has data on more than 40,000 volunteers, approximately half of whom received the vaccine while the other half received a placebo to compare against and judge the vaccine’s efficacy.
Furthermore, the program requires a median follow-up time of two months for safety data. This means that half of the participants have been followed for two months or longer to watch for adverse effects of the vaccine.
While a very large proportion of participants experienced reactions to the vaccine, such as fatigue, headache, and fever, none of these adverse effects met the criteria for halting the trial. In the vaccine group of more than 21,000 participants, there were only four severe adverse events related to the vaccine, but these were transient.
That said, it is important to note that a very large proportion of participants experienced reactions, such as fatigue, headache, and fever. These types of reaction are normal and can be expected as a result of the body’s antibody response to the vaccine—this is how vaccines work.
Thus far, 170 of the study participants have contracted COVID-19 after receiving two injections of either the vaccine or the placebo. The vast majority of those, 168, were in the placebo group. Only eight of those who received the real vaccine contracted the virus. When comparing the two groups, the vaccine was shown to be 95% effective at preventing an infection by SARS-CoV-2, the virus that causes COVID-19.
Even with one dose, which is only half the vaccine regimen, 39 individuals in the vaccine group contracted COVID-19 compared to 82 in the placebo group—this corresponds to a 52% vaccine efficacy after only one dose.
Overall, these results are incredibly promising, and may definitively break the grip of the virus on the country—and not a moment too soon as the country is currently experiencing an explosion in the number of COVID-19 cases.
Even if there is an immediate approval given, the vaccine takes two doses over three weeks to create a maximal antibody response by the fourth week.
Thus, the vaccinations should begin to have a substantial positive effect on the COVID-19 numbers by mid-January.
For that, we should certainly rejoice. The expected approval of this and other vaccines is unequivocally good news.
However, we should temper our expectations, because the vaccines need several weeks to begin having an effect. This means that, unfortunately, even if an authorization comes immediately, the coronavirus vaccine will not be able to lend us much protection before the Christmas travel season, and we will have to take great responsibility for ourselves and for those around us.
As we travel to visit loved ones for the holidays, we’ll still have to be mindful of how infectious COVID-19 is and who in our lives is at great risk, and act accordingly. And policymakers should still pursue mitigation measures other than lockdowns, like rapid-testing.
With that said, news of these vaccines are tremendous developments, and a very welcome Christmas present for us and for the whole world.