How Should We Balance Safety and Urgency in Developing a Covid-19 Vaccine? – The New York Times

Researchers across the world are racing to produce a safe and effective coronavirus vaccine. Currently, 37 vaccines are being tested in clinical trials on humans, and at least 91 vaccines are in the preclinical phase. Russia was the first country to approve a vaccine, but it did so without a Phase 3 trial; now scientists are working to conduct additional trials after receiving international disapproval.

The White House has made optimistic assertions that a vaccine could be ready before the Nov. 3 election, but many scientists, regulators and public health experts are concerned that the rush to distribute a vaccine before it has been fully tested for safety and efficacy is potentially dangerous.

As of Tuesday, Sept. 8, more than 27.4 million people had been infected with the coronavirus worldwide and more than 890,000 had died. Clearly there is a need for speed to put a halt to the spread of the coronavirus and to save lives. And there is a need for safety to create a vaccine that is both effective and not harmful. How should we balance those two important needs?

In the Sept. 4 article Pharma Companies Plan Joint Pledge on Vaccine Safety, Katie Thomas, Noah Weiland and Sharon LaFraniere write about a group of drug companies that said they would not release any vaccines that do not follow rigorous efficacy and safety standards:

Scientists have been rushing at record speed to develop a vaccine that could end the pandemic, which has taken nearly 190,000 lives and infected more than six million people in the United States. Three companies Moderna, Pfizer and AstraZeneca are testing their candidates in late-stage clinical trials.

Pfizers chief executive said this week that the company could see results as early as October, but the others have said only that they plan to release a vaccine by the end of the year.

Public health experts have applauded the companies rapid development of a vaccine, and early results have been promising. But in recent weeks, they have grown worried as Mr. Trump and his allies have begun talking about a vaccine that could be ready before the election on Nov. 3.

Even as companies are competing to be the first to bring a coronavirus vaccine to market, they must navigate perilous political terrain. If they are among the first to bring a successful vaccine to market, they could earn major profits and help rehabilitate the image of an industry battered by rising drug prices.

But if a vaccine turns out to have dangerous side effects for some people, the fallout could be catastrophic, damaging their corporate reputations, putting their broader portfolio of products at risk and broadly undermining trust in vaccines, one of the great public health advances in human history.

In tweets and public comments, Mr. Trump has explicitly tied his re-election fortunes to a vaccine, an idea detailed last week at the Republican National Convention, where promotional videos featured the administrations efforts to fund and develop one in its crash program called Operation Warp Speed.

What goes into making a vaccine and having it approved for public use? In What We Know About the C.D.C.s Covid-19 Vaccine Plans, Carl Zimmer and Katie Thomas detail the stages of vaccine approval:

Once vaccines are designed, they go through four stages of testing. In the preclinical stage, researchers test them on animals. For Covid-19, these animals include hamsters and genetically modified mice, both of which can experience some of the same symptoms as humans.

If these tests yield promising results, then the vaccines go into three phases of clinical trials in people.

In Phase 1, doctors give the vaccine to a small number of volunteers. They keep an eye on them to make sure they dont have any immediate negative reactions. Its not uncommon for people to feel achiness in their muscles or even a mild fever, but these mild symptoms typically dont last long.

In Phase 2 trials, scientists give the vaccine to hundreds of people split into groups, like children and older adults, to determine whether the vaccine acts differently in them. In both Phases 1 and 2, researchers analyze the blood of volunteers to see if their immune systems are learning to fight the virus with antibodies and immune cells that can kill infected cells.

Finally, in Phase 3 trials, scientists give the vaccine to tens of thousands of people and a placebo to tens of thousands of others.

Mr. Zimmer and Ms. Thomas go on to explain the importance of a Phase 3 trial:

In such a trial, volunteers are randomly assigned to receive either the vaccine or the placebo. They dont know which one they are given, nor do their doctors. By blinding the trial, researchers ensure that no bias creeps into the study.

A Phase 3 trial collects data about the symptoms volunteers experience after their injection, and whether they become infected with the coronavirus. After unblinding the data, researchers compare the rates of infection and adverse side effects between people who receive the vaccine and those who receive the placebo.

If significantly more people get Covid-19 on the placebo than the vaccine, that is evidence that the vaccine is effective. The F.D.A. has indicated that vaccine makers should aim for 50 percent protection in order to be considered effective.

If significantly more people who receive the vaccine suffer serious side effects, that may indicate that the vaccine isnt safe or may be safe only for certain groups, like people under the age of 65.

Students, read the rest of the first article, then tell us:

How concerned do you feel about your own health and well-being from the coronavirus? What about that of your family, friends and community? What would an effective and safe vaccine mean to you? What would it mean for the country? The world?

Consider the benefits of expediting the vaccine creation and approval process. Consider the risks. Do you think the benefits outweigh the risks? Why or why not?

Are you concerned that politics and the United States election might affect the vaccine approval process? Are you worried that the Trump administration might be pressuring manufacturers to rush vaccine development for political purposes? Or, do you think any White House pressure is appropriate given the severity of the pandemic and its effects on our health and society?

Are you encouraged by the prospect of a vaccine that could become widely available sometime soon? Or are you worried about it? Do you think drug companies and the Centers for Disease Control and Prevention are doing enough to make sure it is safe and effective? If not, what more could they do?

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How Should We Balance Safety and Urgency in Developing a Covid-19 Vaccine? - The New York Times