• 03:56
  • Wednesday ,16 December 2020

Doctors: After initial concern, this is why we trust the Covid-19 vaccine




Wednesday ,16 December 2020

Doctors: After initial concern, this is why we trust the Covid-19 vaccine

 The two of us, as emergency physicians, will be among the earliest recipients of vaccines against SARS-CoV-2, the novel coronavirus that causes Covid-19.

We have both been asked how and why we made the choice to get our shot. We, like many fellow health care providers, were initially concerned about political pressure being put on the US Food and Drug Administration. Ultimately, though, four reasons, based on our years of experience in emergency medicine, public health and clinical trials, informed our decision to trust the vaccine -- and get vaccinated.The terms "Operation Warp Speed" and "Emergency Use Authorization" convey a haste that could be interpreted as in conflict with safety. History provides examples of vaccines and pharmaceuticals that had negative consequences, so this concern is not unreasonable.However, these vaccines       development did not cut corners. Moderna      s and Pfizer      s compressed timeline reflects unique partnerships between industry, government, and academia, high levels of funding, and decades of previous research on mRNA vaccines, as well as countless individuals working day and night given the nature of the crisis.
Authorization may be expedited, but both organizations followed the requisite orderly progression from Phase 1 to Phase 3 trials. The careful scientific design and rigor has given us a great deal of confidence in the final product.
Despite prior political pressure applied to the process, two federal advisory boards (the FDA and the US Centers for Disease Control and Prevention) as well as a separate advisory board in New York have evaluated Pfizer      s results, and approved the vaccine through the Emergency Use Authorization process. They will follow the same process for the Moderna vaccine.Pfizer      s Phase 3 results have additionally undergone external peer review and been published in the New England Journal of Medicine. Each of these independent reviews was incentivized to identify problems, not to gloss them over. It      s also tremendously unlikely that all of them missed a problem related to safety and efficacy.
They work!
It would not be appropriate to expend massive political, financial, and public goodwill to provide an ineffective vaccine across the population. Reassuringly, the ample publicly available data supports that these vaccines are highly effective in preventing Covid-19 disease.
We love to see consistency of results in science: The fact that the two mRNA vaccines -- Pfizer      s and Moderna      s -- have such similar success rates (over 90% protection against symptomatic Covid-19) is very reassuring and allays concerns that one or the other study was spurious or mistaken. Individual scientists or study groups can certainly make mistakes and be subject to bias, especially when under pressure, but each of these studies was done independently, on slightly different populations, and came to the same conclusions.
We still don      t know the long-term efficacy of the vaccine. Will we need to be vaccinated again in the following year? Perhaps, but right now, we need whatever protection the vaccine can afford us to get on top of the pandemic. And even if the vaccines       effectiveness falls short of the current estimates, the new Covid-19 vaccines promise to be far more effective than most years       flu vaccines.
Side effects are real, but minor, and certainly not as bad as the disease
We are the first to admit that there will be temporary, minor side effects, such as low-grade fevers, muscle aches and fatigue, especially after the second dose of the vaccine. In fact, we have purposefully scheduled our own vaccines for days when we do not have to work clinically.
These side effects are, however, neither dangerous nor long-lasting. Even the worst possible reaction -- anaphylactic allergic reactions -- are both rare and treatable. Administration sites will be on the watch for such events. As ER docs, we are much less worried about vaccine side effects than from the known harm from getting Covid-19.
There is no evidence (or biological plausibility) behind some of the wilder claims that we      ve heard and seen online about the vaccine causing long-term, hidden harm. These allegations mirror the talking points of the anti-vaccine movement. More importantly, they simply are not based in scientific reality.The mRNA just serves as a blueprint for a little piece of protein that stimulates the immune system, is quickly broken down by the body, and it is physically impossible for it to be incorporated into our underlying genetic material.
People with autoimmune disorders were included in the trials, and no increased flares were observed; there is also no potential for their increasing autoimmune disorders, long-term. (If anything, the risk of catching SARS-CoV-2, which causes massive interferon release, should be more concerning to those at risk of autoimmune disease.) We are disheartened by these allegations, but also committed to overturning them with scientific truth.
Most side effects of vaccines show up within days, or at most a few weeks. Trial participants have been monitored for two months or longer. These products are safe, both for us and for our families and patients. From our perspective, the likelihood of harm from Covid-19, in both the short and long term, far outweighs the small potential risks from the Pfizer and Moderna vaccines.
It is not a magic bullet -- but it      s better than getting Covid
It is critical that no one overpromises on the vaccine. It does not cure -- it prevents, and even then, it only reliably prevents infection after the second dose has been received. We don      t currently know how effective it is in preventing asymptomatic transmission. Infection transmission prevention measures (such as masks) must continue for months to come. It is also not fully clear how the logistics of vaccine deployment will play out from state to state.
But at the end of the day, in a year in which we have lost on many fronts, the consistent reported efficacy of these first Covid-19 vaccines is an incredible good fortune.
Vaccines are, perhaps, the greatest miracle of modern medicine. Over the past century, they have had a major role in transforming the life expectancy of the global population, thanks to the acceptance, rather than skepticism, of the general public. And they will continue to help us if we let them.As ER doctors, we have been firsthand witnesses to the horrible effects of this virus. Getting to herd immunity via a devastating down payment of mass illness and deaths is not an option our society can or should bear. Vaccines -- and these vaccines, in particular -- provide a much safer route, with more consistent and long-lasting immunity.
All of this is why we are eager to take our place in line to get our shots -- to protect ourselves, our patients and our families.
It is important to acknowledge the privilege that we have of being able to trust science without the backdrop of sustained experiences of discrimination and systemic harms. The abuses of big pharma and the corporatization of medicine in the United States have driven a wedge between the general population and medical advances, and all the more so for groups who are marginalized or discriminated against.People who have been guinea pigs for science, whose past contacts with health care have been deeply embedded with racism and bigotry, cannot be expected to trust the medical research complex overnight. "Trust us; it      s safe" is a thin promise in the context of people      s life experiences.
Simply because some health care professionals see the vaccine as a beneficial preventive measure doesn      t mean that everyone can see it that way. We believe that the vaccines should be distributed with full consciousness at every level of the inequities embedded in health care and in the pandemic itself. We must commit to fighting for equitable access to other Covid resources for vulnerable communities, concurrent with vaccine recommendation, to mitigate pandemic impact on all possible fronts.