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Don't allow 'vaccine politics' to delay saving lives 

Don't allow 'vaccine politics' to delay saving lives 
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With nearly 3,000 people a day dying of COVID-19, our country faces a renewed, full-blown medical emergency. And yet, the Food and Drug Administration (FDA) has fallen behind the United Kingdom in approving distribution of life-saving vaccines developed here in the United States. Every day that the FDA delays the obvious is a day that thousands of lives may be lost. This delay is inconceivable and, to the extent it may be due to political or public relations concerns, it is unconscionable.

Let’s review the data released on Nov. 18 by Pfizer, which waited to meet an additional wait-and-see period set by the FDA and requiring at least a two-month median period since follow-up with test subjects. The minimum vaccine requirement was 50 percent effective. The two vaccine candidates have blown through that requirement, with no cases of documented severe adverse reaction: 162 subjects who took a placebo got the disease, compared to eight who received the vaccine. Ten severe cases occurred, nine of them among the placebo group. Nearly 4 percent felt fatigue and 2 percent got a headache. These are impressive numbers, far exceeding minimum thresholds.

So why are people being vaccinated in the U.K. but not America?

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Why are we waiting for a mandated public hearing on Dec. 11 after public (not expert) commentary is collected?

It looks more like politics and public relations rather than science — a process designed by bureaucrats looking for political approval. It was all laid out in an October memo from the FDA with a process it said was designed to convince the public that the FDA had not been affected by politics and was being careful enough to convince people it had given the vaccine every possible review. Yet, its actions actually achieved the opposite, as some 40 percent in polls say they are unlikely to take the vaccine.

The best way to convince the public is not through delays and soliciting non-expert online comments but through action. In 1955, Dr. Jonas Salk gave the polio vaccine to his wife and sons, in order to convince people. With the current death toll, anyone with a dose of humanity would rush out a vaccine if they believed in the numbers coming back from the tests.

The pace of science here has been unbelievably fast, and slowing it down is not making the results more believable. The two-month waiting period was one source of delay. Pfizer’s CEO said in an Oct. 16 letter that he expected to announce the initial results of the Phase III study in late October. Mysteriously, Pfizer did not meet that self-announced timetable and waited to look at the results until after the election on the grounds that, as I understand it, announcing its results before the election would have undermined its credibility. Politics intervened to deprive Americans of answers in the fastest possible time — the numbers did not change in that period, only who won or lost the election.

Pfizer may understand the science of vaccines, but political science is something different. The delay was based on the faulty premise that it would increase credibility — yet, while an earlier announcement might have angered an incoming Democratic administration, it also would have been met with added enthusiasm from the other side. Is politics going to become the basis on which science is rolled out? And once Pfizer started to play this game, why shouldn’t the FDA or the governors? I don’t care who benefits or loses politically from scientific findings — lives should come first.

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After Pfizer delayed its announcement and waited to review the results, the FDA pushed back its clock to prepare for a massive public meeting complete with slides and presentations mandated in its memo. Maybe this seemed like a great idea when the virus was on the wane but, with nearly 3,000 Americans dying daily now, this public-relations exercise no longer makes sense. They know the data, they know the risks, they know the hazards — but every day of delay is thousands of lives in the hands of regulators, in the absence of compelling new adverse information.

Politics is now entering the decision even on how to distribute the vaccine. The Centers for Disease Control and Prevention (CDC) website has a very clear chart on deaths by age from COVID-19. There are 6.6 million Americans over age 85, and nearly 80,000 of the 250,000 deaths recorded as of the date of that chart have been among that group. There are nearly 16 million people between the ages of 75 and 84, and nearly 70,000 deaths within that group. There are 31 million aged Between the ages of 65 and 74, and more than 53,000 deaths there. So 80 percent of all deaths are 65 and above. There are just over 54 million Americans in that demographic. Aiming to vaccinate those people in the next 60 days could eliminate close to 80 percent of the deaths, dropping daily mortality from 3,000 to perhaps 600 or fewer. The doses coming online in the next two months could quickly make COVID-19 a paper tiger, if aimed at those groups. Pfizer is making 50 million doses available this month and will produce more than 100 million a month next year; so will Moderna.

The next two age groups down — those between ages 45 and 64 — have about 83 million people. Some triaging to those with hypertension, obesity and other diseases would drop the remaining deaths even faster. Once those age groups are vaccinated, deaths from the virus could be reduced by over 95 percent, and the virus would effectively be over.

Yet, federal authorities are recommending authorizing the vaccine for all 20 million medical workers, a huge waste since most medical workers do not encounter COVID-19 patients and many of them are healthy and in younger age groups. And FDA is discussing making 90 million “essential” workers next, instead of saving the maximum number of lives. Subsets of health care workers and essential workers should be in the top vaccine queues, obviously, but putting all of them first looks like bureaucrats seeking to curry political favor rather than sticking to a scientific mandate of saving the most lives, most quickly.

Over in the U.K., the pecking order already established far more closely follows the life-saving model.

It has been hard to connect a lot of COVID-19 policy to real science instead of political preference. The Supreme Court recently ruled that there were no distinctions of merit in restricting religious meetings relative to marijuana and other kinds of shops and events. Aside from New York Gov. Andrew CuomoAndrew CuomoFracking banned in Delaware River Basin Democratic strategists start women-run media consulting firm Boston's Fenway Park, TD Garden reopening with limited capacity MORE’s deadly edict that COVID-positive patients should be returned to nursing homes, few of the decisions that have been made by anyone have as many lives hanging in the balance as these vaccine decisions. The distribution primarily by age and medical conditions (after relevant high-risk health care and essential workers), rather than by politics, will save the most people and end the virus more quickly. Distribution by political lottery will only prolong the virus.

The choice is clear — but some scientists seem to be infected with the virus of politics, public relations and partisanship. They should stick to statistics, move with all deliberate speed, and save the country by getting the vaccines out without delay.

Mark Penn is a managing partner of the Stagwell Group, a global organization of digital-first marketing companies, as well as chairman of the Harris Poll and author of “Microtrends Squared.” He also is CEO of MDC Partners, an advertising and marketing firm. He served as pollster and adviser to former President Clinton from 1995 to 2000, including during Clinton’s impeachment. You can follow him on Twitter @Mark_Penn.