Fourth vaccine advances, sparking newoptimism
The feverish race for a coronavirus vaccine got an infusion of energy Wednesday as Johnson & Johnsonannouncedthat ithasbegunthe final stage of its clinical trials, the fourthcompany todo so intheunited States as the country hits a grim milestone of 200,000 deaths from the pandemic.
Johnson & Johnson is a couple of months behind the leaders, but its advanced vaccine trial will be by far the largest, enrolling 60,000 participants. The company said it could know by the end of this year if its vaccine works.
And its vaccine potentially has big advantages over some competitors.
It uses a technology that has a long safety record in vaccines for other diseases. It also could require justoneshotinsteadoftwo— important considering that the entire population of the world needs vaccination.
Andit doesn’t have to be kept frozen as it is delivered tohospitals and other placeswhere itwillbe given to patients, simplifying the logistics of hundreds ofmillions of doses.
“Big news,” President Donald Trumptweeted about the trialwednesday morning. “@FDA must move quickly!” he added, referring to the Food and Drug Administration, which oversees vaccine approval.
The president repeatedly has claimed that a vaccine will be ready before Election Day on Nov. 3 and urged federal regulators to act quickly to approve one, raising fears that they will bow to the pressure and rush their vetting process.
The federal government’s Operation Warp Speed program has invested more than $10 billion in private companies’ coronavirus vaccines to date, including about $1.5 billion to Johnson & Johnson to develop and manufacture its vaccine.
Facingcriticismoversecrecy, several companies— including Johnson & Johnson on Wednesday — have taken the rare step of releasing detailed blueprints of their trials, which are typically considered proprietary. And the FDA is expected this week to release stricter guidelines outlining the criteria itwill use to vet clinical trial data.
Never has a vaccine been tested and manufactured so quickly — in months instead of years. Right behind Johnson & Johnson are Sanofi and Novavax, whichmay prove just as good or better than the leading contenders.
“We need multiple vaccines to work,” saiddr. Danbarouch, a virologist at Beth Israel Deaconessmedicalcenterwholed thedevelopment of the technology used in Johnson& Johnson’s trial. “There are 7 billion people in the world, and no single vaccine supplierwillbe able tomanufacture at that scale.”
Johnson & Johnson’s advanced trial, known as a Phase 3 trial, started Monday. At a news conference, Dr. Paul Stoffels, the company’s chief scientific officer, said the companymight be able to determine by the end of the year if the vaccine is safe and effective. The company soon will post a manuscript online with data from the earlier phases of its trials, he said.
He said he expected to have tens of millions ofdoses readybytheend of the year.