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Scientists are scrambling to develop a vaccine for Covid-19, which has already claimed the lives of 259,796 people from around the world.
Yet while more than ever before, pharma, biotechs, start-ups, research institutes and universities are working together to develop a vaccine and identify new therapies to treat the symptoms of this disease, we most likely won’t see a vaccine until the end of 2021, according to Dale Fisher, chair of the World Health Organization’s Global Outbreak Alert and Response Network. That’s because of the Phase 2 and 3 trials that are necessary to guarantee both safety and efficacy and the need to ramp up production and distribution, he says.
CNBC’s Meg Tirrell has been following the developments closely since the outbreak was identified in Wuhan, China, in December 2019. Here, the senior health and science reporter shares her insights on the most promising vaccines and treatments in development right now and how the coronavirus pandemic may affect drug development in the future.
President Donald Trump made headlines this weekend, saying he believes the U.S. will have a vaccine for the coronavirus by the end of the year. In your discussions with pharmaceutical companies, what timeline are they giving now?
The timelines pharmaceutical companies are talking about for Covid-19 vaccines would set records many times over. Pfizer, which is partnered with German biotech company BioNTech, said this week it aims to have millions of doses ready by the end of this year, and hundreds of millions next year. That’s if all goes well with safety and efficacy testing in thousands of people before then.
And it’s not even the first into human testing: Moderna, which partnered with NIAID; Inovio, a team at Oxford University, which now partnered with AstraZeneca; and several Chinese companies have already begun trials. But these timelines — having a vaccine to actually deploy by early next year — require everything going right, and going right the first time. That rarely happens in drug development.
What are the most promising vaccines and treatments in development right now?
The vaccine race is anybody’s game. There is new technology being deployed by both Moderna and Pfizer/BioNTech, known as messenger RNA. That’s allowed those companies to move at incredibly fast speeds — but it’s also a drawback in that no drug or vaccine based on mRNA has ever reached the market, so there are many questions, including about safety and efficacy.
The team at Oxford is using an approach they’ve already tried in other coronaviruses, so they may have a head start (they started their trials in people in April). Meanwhile, Johnson & Johnson, which has tremendous credibility in vaccine development in outbreak scenarios after developing an Ebola vaccine, says it aims to start human trials in September.
On the treatments front, other than Gilead’s remdesivir, which has received its share of ink in the last month, one of the nearest-term hopes is Regeneron’s antibody approach. The company successfully developed an antibody drug for Ebola that proved effective in a clinical trial in the Democratic Republic of Congo, and it’s doing the same thing for Covid-19, with plans to enter human trials in June.
They expect they could get data on how well their drug works one to two months later. If it does work, it could provide a bridge to a vaccine and to other drugs (specifically, easier-to-take pills in development for Covid-19 at Pfizer and other drug companies, and in the lab of AIDS research pioneer David Ho. The expectation is pills like this could be taken earlier in the course of the disease or even preventively.
There has been much confusion around testing — both for Covid-19 and antibodies. What is the state of play now? Are we testing enough people and with the right tests?
No. Testing for current infection is increasing, but is not at the level experts say it should be to allow us to safely reopen. That’s because there are still difficulties in the supply chain: not enough swabs, PPE for people taking the swabs, and not enough reagents to run the tests. These things are improving, but the problems aren’t yet solved. And new technologies are being worked on to increase testing capacity.
Meanwhile, there are also antibody tests available — in fact, too many. The FDA this week tightened its policies around antibody tests after observing what it called “unscrupulous actors marketing fraudulent test kits.” Antibody tests look in the blood for evidence of prior infection. These tests could be really helpful — if we knew for sure how long antibodies provide protection against future infection. Meanwhile, even the tests authorized by the FDA aren’t perfect, so former FDA Commissioner Dr. Scott Gottlieb recommends anyone receiving a positive result the first time get another test, just to be sure.
Major pharmaceutical have dramatically compressed their drug development timeline, and the FDA has issued dozens of emergency-use approvals, for both treatments as well as tests. Do you think this will lead to new models for drug development in the future, post-crisis?
Yes and no. The FDA and regulators around the world are being extremely flexible during this pandemic, but that likely won’t carry through completely to other diseases in non-emergency situations. One lasting effect I wonder about is a renewed focus on infectious disease; it’s largely been an abandoned area by large pharmaceutical companies, with a few exceptions, and there hasn’t been much success in treating viruses in particular, outside of HIV and hepatitis C. Will all of this investment now bring in a renaissance in antiviral drug development and a renewed support for vaccines? We can only hope.
What are some of the key things you hope to learn from our speakers at Healthy Returns?
Can they really do it? These scientists and business leaders are being asked both to shorten development timelines by unprecedented amounts and to simultaneously scale manufacturing by orders of magnitude. They’re being pressured by governments around the world to ensure supply, while their plans for pricing are being demanded by patient-access groups and Wall Street analysts alike. All before they even know if their drugs and vaccines work.
The world is counting on them. We’re going to learn firsthand how they’re responding.
JOIN IN: For more in-depth coverage from our CNBC anchors and reporters with health-care CEOs and industry leaders, request to join the Health Returns Virtual Summit on May 12.