Tag Archives: coronavirus vaccine

The Differences Between the Vaccines Matter

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Hilda Bastian, The Atlantic: March 7, 2021

Public-health officials are enthusiastic about the new, single-shot COVID-19 vaccine from Johnson & Johnson, despite its having a somewhat lower efficacy at preventing symptomatic illness than other available options. Although clinical-trial data peg that rate at 72 percent in the United States, compared with 94 and 95 percent for the Moderna and Pfizer-BioNTech vaccines, many experts say we shouldn’t fixate on those numbers. Much more germane, they say, is the fact that the Johnson & Johnson shot, like the other two, is essentially perfect when it comes to preventing the gravest outcomes. “I’m super-pumped about this,” Virginia’s vaccine coordinator told The New York Times last weekend. “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.”

The same glowing message—that the COVID-19 vaccines are all equivalent, at least where it really counts—has been getting public-health officials and pundits super-pumped for weeks now. Its potential value for promoting vaccination couldn’t be more clear: We’ll all be better off, and this nightmare will be over sooner, if people know that the best vaccine of all is whichever one they can get the soonest. With that in mind, Vox has urged its readers to attend to “the most important vaccine statistic”—the fact that “there have been zero cases of hospitalization or death in clinical trials for all of these vaccines.” The physician and CNN medical analyst Leana Wen also made a point of noting that “all of the vaccines are essentially a hundred percent” in this regard. And half a dozen former members of President Joe Biden’s COVID-19 Advisory Board wrote in USA Today, “Varying ‘effectiveness’ rates miss the most important point: The vaccines were all 100% effective in the vaccine trials in stopping hospitalizations and death.”

There’s a problem here. It’s certainly true that all three of the FDA-authorized vaccines are very good—amazing, even—at protecting people’s health. No one should refrain from seeking vaccination on the theory that any might be second-rate. But it’s also true that the COVID-19 vaccines aren’t all the same: Some are more effective than others at preventing illness, for example; some cause fewer adverse reactions; some are more convenient; some were made using more familiar methods and technologies. As for the claim that the vaccines have proved perfectly and equally effective at preventing hospitalization and death? It’s just not right.

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The data were indeed suggestive of an encouraging idea. Based on the numbers so far, we can expect the vaccines to provide extremely high levels of protection against the most dire outcomes. Still, we don’t know how high—and it’s clear they won’t uniformly cause hospitalizations and deaths from COVID-19 to disappear in vaccinated people.

The experts understand this, of course. Gandhi has been updating her table as more data come in, and now pegs Moderna’s efficacy on that front at 97 percent; Jha has since tweeted that “nothing is 100 percent … But these vaccines sure are close”; and Topol told The Atlantic that the numbers in his tweet are not a sufficient basis from which to draw “any determination of magnitude of effect,” though the fact that they all point in the same direction is “very encouraging.” Still, the message of perfection that their initial tables and tweets spawned—the gist, for many readers, of all those 100s and zeros—has since been picked up far and wide, and misinterpreted along the way.

For the AstraZeneca vaccine, one person in the control group had severe COVID-19, but eight people were hospitalized; for Johnson & Johnson, 34 people in the placebo group had severe COVID-19, but only five people were hospitalized. It’s true that zero vaccinated people were hospitalized in either study after the vaccines took effect. But with numbers that small, you can’t draw a reliable conclusion about how high efficacy may be for these outcomes. As Diana Zuckerman of the National Center for Health Research pointed out about the Johnson & Johnson trial, “It’s misleading to tell the public that nobody who was vaccinated was hospitalized unless you also tell them that only 5 people in the placebo group were hospitalized.” She’s right. And you can’t be confident about predicting effectiveness precisely in a wider population outside the trial, either. For example, some of the vaccine trials included relatively few people older than 60 as participants.

You can see how fragile these numbers are by looking at those compiled for severe disease. In the Pfizer trial, for example, just one vaccinated person developed severe COVID-19 versus three in the placebo group—which meant that a single bout of disease made the difference between a calculated efficacy rate of 66 percent and one of 100 percent. For the Novavax and Oxford-AstraZeneca trials, there were zero people with severe disease in the vaccinated group versus only one in the control group, so adding or subtracting one would have been even more dramatic. The problem is even greater for deaths. For that efficacy analysis, only two of the vaccine trials—for Moderna’s and Johnson & Johnson’s—reported any COVID-19 deaths at all in the control groups.

It’s also important to remember that these are early results: Some people who enrolled very late in the trials aren’t yet included in reported data, and analysis is still under way. Indeed, the FDA pointed out in December that one vaccinated person in the Moderna trial had been hospitalized with apparently severe COVID-19 two months after receiving a second dose. That person was in a group still awaiting final assessment by the researchers, and was not mentioned in Moderna’s formal readout of results.

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“The idea that people can’t handle nuance,” Jha tweeted at the end of February, “it’s paternalistic. And untrue.” I couldn’t agree more. The principle of treating people like adults is fundamental. We don’t need to exaggerate. Talking about the trade-offs between different medicines and vaccines is often complicated, but we do it all the time—and we can do it with COVID-19 vaccines too.

To read the entire article, click here. 

J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel

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Kerry Dooley Young, Medscape Medical News: February 26, 2021

An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine.

The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?

The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.

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Weakened Standards?

Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.

They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.

“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.

“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Doshi said.

Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.

The FDA’s June 2020 guidance on the development of COVID vaccines had asked drug makers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Doshi said.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.

“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Zuckerman said.

Read the entire article here. 

What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine

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Tina Hesman Saey, ScienceNews: February 27, 2021

And then there were three: A single-shot vaccine is the latest weapon to join the battle against COVID-19 in the United States.

On February 27, the U.S. Food and Drug Administration gave emergency use authorization for Johnson & Johnson’s vaccine against SARS-CoV-2, the coronavirus that causes COVID-19. South Africa is the only other country to OK Johnson & Johnson’s vaccine so far, though other countries are poised to follow suit.

The FDA determined that Johnson & Johnson’s vaccine meets the criteria for safety and effectiveness and that there is clear evidence that it may prevent COVID-19, the agency said in a statement.

“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks,  director of the FDA’s Center for Biologics Evaluation and Research.

Its authorization for emergency use in the United States – for people age 18 and older – follows similar authorizations in December for vaccines made by Moderna and by Pfizer and its German partner BioNTech.

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As of February 25, more than 52,000 people were hospitalized in the United States fighting COVID-19, according to the COVID Tracking Project. That’s down from the record-setting daily peaks of more than 130,000 in early January and the lowest since early to mid-November. More than half a million people in the United States have now died from COVID-19.

In Johnson & Johnson’s clinical trial, two of the 19,514 people in the vaccine group were hospitalized with COVID-19 starting 14 days after vaccination. That compares with 29 hospitalizations among the 19,544 people in the placebo group. None of the vaccinated people died, but there were seven deaths related to COVID-19 in the placebo group. Those numbers are small and some researchers say the data aren’t clear-cut on the benefits.

“The data indicate that the vaccine is effective, but doesn’t prove that the vaccine is especially effective against moderate to severe COVID,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based think tank that analyzes health research.

The data were also collected after only two months of follow-up. Normally, the FDA requires a year or more of data to fully approve a vaccine. Some questions about the vaccine can’t be answered with less than six months of data, Zuckerman said during a public comment period in the Feb. 26 advisory board hearing.  “Let’s be very honest with the public about what we do know and what we won’t know” for some time to come.

For all the vaccines, no one knows how long immunity will last. And what’s already authorized might need to be tweaked if resistant variants become widespread. Booster shots may be needed, Benjamin says.

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To read the entire article, click here.

HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

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Brandon Lee and Alex Ruoff, Bloomberg Government: October 23, 2020

U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. 

Read the full article here. 

FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine

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Noel King and Sydney Lupkin, NPR: October 22, 2020

NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

Read or listen to the full article here. 

FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

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Thomas M. Burton, Wall Street Journal: October 23, 2020

SILVER SPRING, Md.—Food and Drug Administration officials gave fresh assurances Thursday that Covid-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review. But some speakers and panel members raised concerns about whether the FDA’s vaccine guidelines for Covid-19 clinical trials are sufficiently rigorous.

These comments came at the first meeting of a 25-member panel of medical experts, including specialists in fields like virology, infectious diseases and biostatistics. The group, which met remotely via video-conferencing, was  established to make recommendations to the FDA on how best to assess the safety and effectiveness of vaccines.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

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President Trump has pushed to get a vaccine approved quickly, which has drawn concern from some public health experts and political opponents that the FDA would be under pressure to bypass usual precautions to rush a vaccine to market quickly.

FDA officials have vowed not to do so. In addition to convening the advisory panel, they have issued a set of guidelines to govern how vaccine clinical trials will be conducted and evaluated.

They also formulated a set of rigorous standards for the FDA to employ before granting what is known as an emergency-use authorization (EUA) for a vaccine. The EUA is the faster equivalent during the Covid-19 pandemic of a conventional approval by the agency.

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Various speakers questioned whether the shorter EUA test period was sufficient.

“The vaccine trials have serious design flaws,” said Diana Zuckerman, president of the National Center for Health Research in Washington. In addition to the two-month period, she said FDA guidelines focus on measuring milder cases of the disease, and not the most serious cases.  

Read the full article here.