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How the Out-of-Control Pandemic Is Speeding the Hunt for Vaccines

The coronavirus is spreading out of control in the United States, overwhelming health systems and killing more than 1,100 Americans a day. But there is a slender silver lining: It is hastening the testing of vaccines that could eventually end the pandemic.

The surging virus has already allowed Pfizer and Moderna to accelerate the testing of their vaccines, which appear to be very effective at preventing Covid-19.

And if, as seems inevitable, the virus continues to proliferate — it is spreading faster than ever in the United States and some other countries — it is likely to speed the evaluations of promising vaccine candidates from other pharmaceutical companies.

“We are seeing something apocalyptic play out in terms of the level of transmission in the country right now,” said Dr. Peter Hotez, a vaccine scientist at the National School of Tropical Medicine at Baylor College of Medicine. “Unfortunately, this pandemic is still raging, and that affords lots of opportunities to look at vaccine efficacy.”

Over the last week, an average of more than 158,000 new coronavirus cases have been confirmed each day in the United States. More than 159,000 were reported on Tuesday.

In late-stage vaccine trials, the faster that participants get sick, the faster that drug developers gain enough data to know whether their vaccines are effective.

Researchers determine how well a vaccine works by comparing the rate at which volunteers who receive a placebo get sick versus the rate for those who receive a vaccine. If the vaccine offers strong protection, the number of people who get the placebo and then fall ill will far exceed the number of vaccinated people who get sick.

The trials are designed so that once a certain number of participants contract Covid-19, an independent panel of experts will conduct a preliminary examination of the data. (Other factors, such as how much time has passed since participants have been vaccinated, can factor into that timing, too.) The trial ends after a certain number of cases — around 150 to 170 — have accrued. That number is chosen to make sure the results have sufficient statistical power to tell how well the vaccine works.

Pfizer announced on Wednesday that its vaccine was 95 percent effective and had no serious side effects. The company, along with its German partner BioNTech, reached those findings after 170 participants in its trials — the vast majority having received a placebo — contracted Covid-19.

The news came barely a week after a preliminary analysis found Pfizer’s vaccine to be more than 90 percent effective. That data was analyzed after 94 participants caught Covid-19, nearly three times the number that the company had originally planned would set off an early look to gauge the vaccine’s efficacy.

The same phenomenon aided Moderna, which announced on Monday that an early analysis had found its vaccine to be 94.5 percent effective. The company had planned on needing only 53 cases of Covid-19 to turn up in its trial before experts would take a first look at the data. But the nationwide surge in infections helped Moderna blow past that number: The results were based on 95 sick participants.

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Credit…Agence France-Presse — Getty Images

The relatively large numbers of sick people in the trials — coupled with the vaccines’ apparent effectiveness — could help bolster public trust.

“It’s going to be hard enough to convince people to take this vaccine as it is,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink. “So the more confidence you can have, by virtue of having higher statistical power, by virtue of having more events — then that should go somewhere.”

In the coming weeks and months, the worsening pandemic could make results from other closely watched trials, such as one for a vaccine developed by Johnson & Johnson and another by AstraZeneca and the University of Oxford, available sooner and with greater statistical power.

The fast-growing pandemic could also speed up trials of treatments for Covid-19.

The drug company Regeneron, for example, is testing the antibody treatment that President Trump received after he caught Covid-19. A company spokeswoman said enrollment in its trial — participants are Covid-19 patients who have not been hospitalized — had accelerated slightly this month.

Even if the grim situation in the United States ultimately helps vaccines and treatments become available sooner, the country would have been much better off if it had kept the pandemic under control, public health experts said.

“This is not how anyone would want it to play out,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. “I’d rather be South Korea,” which has kept the virus at bay since early in the year, she said.

Vaccines are unlikely to be widely available for months. By then, tens of thousands of additional Americans will probably have perished.

Pfizer and Moderna, whose vaccines appear effective, have been waiting to see if side effects pop up in participants before the companies submit their data to the Food and Drug Administration for authorization to distribute the vaccines. Once the F.D.A. gives them the green light, manufacturers will have to ramp up production and work with governments to distribute the vaccines. Shots will initially be available only for health care workers and other vulnerable groups. When vaccines do become widely available, it is not clear if their protection will last for months, years or decades.

Hoping to fast-track their testing, drug makers have been setting up trials in Covid-19 hot spots all over the world — not just in the United States.

In China, where the virus was rampant early this year, new cases have slowed to a trickle. As a result, Chinese vaccine makers are running late-stage trials of their candidates in countries like the United Arab Emirates, Morocco, Argentina and Peru.

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Credit…Reuters

Novavax, based in Maryland, which is developing one of the 12 vaccines that are in the final phase of clinical testing, has enrolled more than 9,000 participants in Britain since beginning a Phase 3 trial there in September. Novavax’s president for research and development, Dr. Gregory Glenn, told analysts last week that he was “feeling very good about our ability to collect cases.”

Britain reported more than 20,000 new cases on Tuesday, part of a surge that picked up around the start of October.

Dr. Glenn added: “If you’re in the right spot at the right time, you can very quickly accumulate cases. I think we are in the right spot at the right time in the U.K.” Novavax plans to start a Phase 3 trial in the United States this month.

Vaccine developers select different parts of the world to conduct their trials for several reasons. They need to ensure that the vaccine has been tested on populations that reflect the world’s diversity. They also must make sure they can enroll participants in regions where the virus is spreading.

“What is a hot spot initially will not necessarily stay a hot spot,” said Dr. Dean of the University of Florida, who has studied how to make clinical trials flexible enough to work during epidemics.

That’s why developers testing Covid-19 vaccines have been carefully watching where the virus is surging to make decisions about where to set up sites to enroll participants.

Johnson & Johnson is testing one version of its vaccine in the United States and other countries. The trials — which are set up or planned at more than 200 locations globally, including in 30 states — were chosen in part by modeling the case numbers in different regions, said Jake Sargent, a company spokesman.

Johnson & Johnson announced on Monday that it had started another trial of its vaccine, testing two doses instead of one. The company aims to enroll 30,000 participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, Britain and the United States. Johnson & Johnson said the locations were chosen “in countries and areas with high incidence of Covid-19.”

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Covid-19 Vaccines Offer Drug Makers Chance at Salvation, Financial and Beyond

For a long time, drug makers have been the most hated industry in America. Companies are blamed for gouging prices on lifesaving drugs and enriching themselves through the opioid crisis, among other sins.

Now, with pharmaceutical companies racing to find vaccines to end the coronavirus pandemic, the industry is hoping to redeem itself in the public’s mind.

The primary goal, of course, is to rescue the world from the grips of a vicious virus. But a big fringe benefit is to get public credit — and to use an improved image to fend off government efforts to more heavily regulate the industry.

Consider Johnson & Johnson, one of the world’s largest health care companies.

In recent years, its reputation has been battered by accusations that products like its artificial hips and talcum powder have harmed customers. In 2019, an Oklahoma judge ordered the company to pay $572 million for contributing to the opioid epidemic.

This spring, Johnson & Johnson jumped into the hunt for a Covid-19 vaccine; its candidate is now in the final stage of clinical trials. (On Monday, the company said it had temporarily paused the study after a participant became sick with an unexplained illness.)

Regardless of whether the vaccine ever comes to market, the company is looking to create a surge of positive publicity from its work. Its chief executive, Alex Gorsky, went on the “Today” show this spring and called Johnson & Johnson’s lab workers heroes. The company has produced a slick, self-promotional online video series, “The Road to a Vaccine,” featuring feel-good interviews with the company’s scientists and segments on issues like whether it is safe to send children back to school.

Johnson & Johnson’s efforts to develop a vaccine will show that “J&J is a company full of people with heart and soul who are doing this 24-7, with all their science and know-how,” Dr. Paul Stoffels, the company’s chief scientific officer, said in an interview. While the company’s image at times has been “trashed,” he said, “I hope that we can get to a better reputation.”

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Credit…Brendan Mcdermid/Reuters

That is a widely held sentiment across the pharmaceutical industry. Companies are looking for public makeovers as a political battle over drug price controls looms. Others are seizing the once-in-a-generation opportunity to raise money for future projects from investors and the government.

For an industry demonized by consumers and politicians, the hunt for a vaccine “offers a path to redemption,” said J. Stephen Morrison, a senior vice president at the Center for Strategic and International Studies, a think tank in Washington.

Last fall, a Gallup poll found that drug makers had the worst reputation of any American industry. Americans were twice as likely to rate the industry negatively as positively. Drug companies were even less popular than the federal government.

The pandemic — and the high hopes for a fast, safe, effective vaccine — appears to be changing that perception, at least for now. This spring, other opinion polls showed that Americans’ views of the industry were improving.

When Gallup released the results of this year’s annual survey, conducted in the first half of August, the results confirmed that the pharmaceutical industry’s reputation had gotten a bit better. Now, it is second-to-last, having inched past the U.S. government.

Public opinion matters. The industry is facing a fight in Washington over price controls, which could take a bite out of companies’ profits in the United States. The latest salvo came last month when President Trump issued an executive order that called for capping the costs of some prescription drugs.

The industry’s largest trade group, the Pharmaceutical Research and Manufacturers of America, is fighting back by invoking the industry’s effort to fight the coronavirus. It denounced Mr. Trump’s executive order as “a reckless attack on the very companies working around the clock to beat Covid-19.”

Kim Monk, managing director of Capital Alpha Partners, a policy research firm based in Washington, said that finding a safe and effective vaccine could help drug companies in their campaign to stave off price controls. “You don’t even need to say it,” she said. “It’s part of the strategy.”

To be sure, the race for a coronavirus vaccine is much more than a public relations play. Scientists at pharmaceutical companies take great pride in their work to combat human suffering. And there is immense prestige involved in being among the first to successfully conquer a devastating global pandemic.

There are also potentially enormous profits on the line.

Vaccines are often thought of as the pharmaceutical industry’s sleepy, low-profit backwater, but that is not always the case, said Dr. David Bishai, a professor of health economics at Johns Hopkins University’s school of public health.

Prevnar, a vaccine to prevent pneumococcal disease, which leads to ear and sinus infections, is Pfizer’s top-selling product, responsible for nearly $6 billion in revenue last year.

Merck’s Gardasil, which protects against human papillomavirus, a sexually transmitted disease that can cause cervical cancer, generated close to $4 billion in sales last year, making it the company’s third-best seller.

While drug makers generally do not disclose what they earn on individual drugs, two of the world’s largest pharmaceutical companies, GlaxoSmithKline and Sanofi, have said in securities filings that the profit margins in their vaccine divisions are greater than in their other lines of business.

Ronny Gal, an analyst at Bernstein, estimated that sales from a coronavirus vaccine could be up to $20 billion in the first year alone. And since diseases are rarely eradicated, vaccines “tend to be a very long-term business,” he said.

Two leading drug makers have pledged to not profit from their vaccines. But those promises are laden with caveats.

Johnson & Johnson has said it will sell the vaccine on a “not-for-profit” basis for “emergency pandemic use.” But the company hasn’t explained in detail how it will define “not for profit.” In any case, when the “emergency pandemic” phase of the crisis ends, the company will no longer be bound by its pledge. Jake Sargent, a Johnson & Johnson spokesman, said the end of the emergency phase “will be defined at a future date by global health authorities.”

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Credit…Erin Schaff/The New York Times

Another major drug company, AstraZeneca, has made a similar pledge not to profit on its vaccine, which is also in large clinical trials, during the pandemic. But in a contract with one of its manufacturers, AstraZeneca has suggested that it can declare the pandemic to be over as soon as July 2021 — around the time that a successful vaccine is likely to be getting sold worldwide, according to the Financial Times.

“The company has committed to supplying the potential vaccine at no profit during this pandemic period,” said an AstraZeneca spokeswoman, Michele Meixell. “It is too early to determine pricing post-pandemic.”

The Covid-19 vaccine business is likely to be unusually lucrative because much of the risk has been taken out of the equation. The federal government has entered into deals with companies totaling more than $10 billion to develop, manufacture and distribute coronavirus vaccines. Drug companies usually spend small fortunes to market their products. But that will probably not be required to generate public interest in a coronavirus vaccine.

“If you get a vaccine and it gets recommended by the C.D.C., you barely need a sales force,” said Geoffrey Porges, the director of therapeutics research at the investment bank SVB Leerink.

A successful vaccine could be a transformative moment for unproven companies like Moderna and Novavax, which have never previously brought vaccines to market. But even being involved in the race is proving financially fruitful for smaller firms.

The German biotech firm CureVac, which says it hopes to have a successful vaccine by the end of the year, raised $245 million in August when it began trading on the Nasdaq. It is now valued at nearly $10 billion, despite never having brought a product to market.

Ms. Monk of Capital Alpha Partners said drug makers large and small are likely to benefit from any association with fighting the coronavirus. “For an industry that is not viewed favorably by the public,” she said, “this is a real opportunity for them to put on a white hat and save the world.”

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