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More safety data would be nice, but we need a vaccine now

On Monday Pfizer and partner BioNTech announced data showing their vaccine can be 90 percent effective in reducing symptomatic Covid cases. This is an amazing achievement, albeit for the time being. After tens of thousands of vaccine recipients, there have been no serious safety concerns. The main question now becomes how quickly can we safely get this vaccine to the public.

The timing here has been a source of controversy. Current guidelines for Covid vaccines from the Food and Drug Administration require a two-month follow-up examination for at least half of the subjects in a clinical trial before approval can be granted to ensure that sufficient safety data has been collected. Pfizer now estimates that this two-month threshold will be reached in the third week of November. Six weeks ago, more than 60 prominent medical figures – including several who have since been appointed to Joe Biden’s Covid-19 task force – wrote a letter to Pfizer’s CEO asking them to follow up for at least two months everyone in medicine asked the process that would slow the process down by at least a month or two. “Submitting an application for a [Emergency Use Authorization] Before this standard is met, public confidence would be severely undermined and comprehensive vaccination efforts would be scaled back, ”they wrote. A few weeks prior to writing, others raised concerns about the existence of an emergency approval for a Covid vaccine, arguing that we should wait for the full approval process to complete. This would delay a vaccine well into next year. “We don’t do EUAs for vaccines,” vaccine expert Peter Hotez told Yahoo News. (Hotez later signed the letter to Pfizer.) “It’s a lesser rating, it’s a lesser quality rating, and if you’re talking about vaccinating a large part of the American population, that’s unacceptable.”



Walid Gellad (@walidgellad) is a doctor and policy researcher at the University of Pittsburgh, where he directs the Center for Pharmaceutical Policy and Prescribing.

Now that we finally have some promising efficacy results and the country is nearing what one expert calls the onset of “Covid Hell,” it may not be a good idea to wait any longer. The right length of time to wait for more safety data should depend on how well a vaccine is working and how badly we need it – and we need it badly. More than 1,000 Americans die every day. Hospital admissions are skyrocketing, putting serious pressure on healthcare systems in Utah, Ohio, Texas, Missouri, Oklahoma, and other states. There is no coherent national strategy for masking or social distancing. and Thanksgiving is just around the corner, and travelers will spread the seeds of Covid across the country. A mild influenza season is hope, not a guarantee. If worse is on the way then the arguments of waiting another month or three or six to get a vaccine on the market seem ill-advised.

But how sure do we need to be about the safety risks of the vaccine before we can decide that the benefits are likely to outweigh the risks? In fact, even the FDA two-month guideline is arbitrary. FDA experts recognize that most vaccine side effects appear within 6 to 8 weeks of vaccination, although some rare adverse events will not occur for three months or even longer. Questions also remain as to how long the vaccine will last and whether it will work for all groups of people. But we don’t have the luxury of waiting. Each week that goes by, 7,000 more deaths and orders of magnitude more severely from the pandemic.

The landscape was already different in August and September, when some experts suggested waiting longer for further safety data. The trend lines for the disease were flatter. A vaccine effectiveness of 90 percent was not expected. There were real safety concerns given previous episodes where vaccines, which initially appeared effective, made the disease worse. And there was politics too – fears that White House pressure would lead to irresponsible decisions (as some believed was hydroxychloroquine and convalescent plasma), or perhaps an aversion to having a successful vaccine emerge before the election, or maybe a mixture of both. It turns out, with a bit of irony, that Pfizer originally planned to review its vaccine clinical trial data earlier, but decided against it, given public pressure and after unspecified discussions with the FDA. Had the company checked earlier, it would likely have seen the same level of effectiveness a few weeks ago. During that time, thousands of lives have been lost or damaged by the pandemic.

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As the environment for a Covid vaccine has now changed, the weighing of risks and benefits should also change. Instead of waiting until December for an outside advisory board to review the vaccine dates, which the FDA promised to do before getting a vaccine approval, we should plan to do so before the end of the month. Pfizer may attempt to “skew” its data analysis and keep safety data on Thanksgiving ready for committee review, even if that meant that only 40 or 45 percent of the study participants, instead of half of them, took at least two months Follow-up.