Coronavirus Vaccine Race On: Pfizer Says U.S. Testing to Start Next Week

The race for a vaccine to combat the new coronavirus is moving faster than researchers and drugmakers expected, with Pfizer Inc. joining several other groups saying that they had accelerated the timetable for testing and that a vaccine could be ready for emergency use in the fall.
Pfizer said Tuesday it will begin testing of its experimental vaccine in the U.S. as early as next week. On Monday, Oxford University researchers said their vaccine candidate could be available for emergency use as early as September if it passes muster in studies, while biotech Moderna Inc. said it was preparing to enter its vaccine into the second phase of human testing.
Johnson & Johnson said earlier this month it shaved months off the usual timelines for developing a vaccine, and expects to start human testing of a coronavirus candidate as soon as September, with possible availability on an emergency-use basis in early 2021.
“This is a crisis right now, and a solution is desperately needed by all, ” said Pfizer Chief Executive Albert Bourla.
The experimental vaccines still face a gauntlet of testing to make sure they work safely, which could derail efforts. Many promising drugs and vaccines wind up faltering during rounds of study.
Adding to the potential obstacles, researchers say, is the fast-moving nature of the virus and measures to limit its spread. They have complicated efforts to set up some studies and find patients for research, delaying efforts and even closing some trials.
Yet research into a coronavirus vaccine has moved at a relatively rapid clip, infectious-disease experts say.
“I’m not aware of any vaccine that’s been developed after only a year to a year-and-a-half after identifying a pathogen. It usually takes years,” said Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta. “People are moving very, very quickly with this.”
The effort has been expedited, Dr. Orenstein said, by rapid discoveries about the virus and vaccine-making technologies. Yet he said he is skeptical a safe and effective vaccine could be available soon, given all the testing required.
Vaccines can take years to hatch and then test to make sure they work safely — so long that researchers weren’t able to ready vaccines against previous viral outbreaks like Ebola in West Africa before they had petered out.
There aren’t any drugs or vaccines that have been proven to fight off the new coronavirus and are approved for use. Before granting approval, federal health regulators can authorize an experimental vaccine’s use during a public health emergency.
New York-based Pfizer is working on vaccine candidates with Germany’s BioNTech SE. The shots are based on an emerging gene-based technology known as messenger RNA, or mRNA, which carry instructions from DNA to the body’s cells to make certain proteins.
Testing of a vaccine, which has already started in Germany, could start in the U.S. as early as next week if health regulators sign off, Pfizer’s Mr. Bourla said. Results from the study could come as early as next month, he said.
If further testing also proves successful, Pfizer could start distributing the vaccine on an emergency basis in the fall and receive approval for widespread distribution by year’s end, Mr. Bourla said.
Pfizer is investing $500 million in coronavirus vaccine and drug research, and is spending another $150 million to ready its manufacturing capabilities so the company can quickly make large quantities of antiviral agents, including a vaccine that succeeds in testing.
“You can imagine the demand for something like that will be extremely, extremely high,” Mr. Bourla said.
Oxford University researchers last week began vaccinating people for a 1,100-subject study testing the safety of their candidate and monitoring its efficacy, according to Adrian Hill, director of the university’s Jenner Institute, which develops vaccines.
If the vaccine candidate proves safe, the researchers aim to explore whether it protects against the coronavirus in a 5,000-subject trial starting in late May, Dr. Hill said.
The researchers could know whether the vaccine works by September, and emergency distribution could begin as early as that month. “That is the target timeline. It will be tough to do that, but it is not impossible,” Dr. Hill said. The New York Times reported Monday on the Oxford group’s progress.
Moderna, which is also developing an mRNA vaccine, said it had asked the U.S. Food and Drug Administration to authorize the next phase of testing, a standard request before starting a new vaccine trial, and it could begin as early as May.
The study would test the experimental vaccine in about 600 healthy volunteers to see if it was safe and triggered the production of antibodies that could neutralize the coronavirus.
If the vaccine shows signs of working safely in the study, Moderna said the third and final phase of testing could start in the fall. The company said it could seek FDA approval to sell the vaccine by year’s end, if it succeeds in testing.
Merck & Co., a longtime maker of vaccines, said it is talking to potential partners about three different technologies to manufacture coronavirus vaccines.
Merck Chief Executive Ken Frazier said Tuesday drugmakers will need to develop more than one coronavirus vaccine to meet demand world-wide. He also said different vaccines might have different profiles that could benefit certain groups of people over others.
“It could be that the vaccines that very older people need who are very vulnerable may be different, for example, than the vaccines that you would give to healthy children,” Mr. Frazier said.
Mr. Frazier wouldn’t provide potential timing for Merck’s coronavirus vaccine efforts, though he said he doesn’t view the company as behind rivals even as their vaccines have begun testing in patients.

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