Johnson & Johnson is a key player in the coronavirus vaccine race. The company is developing and testing its experimental COVID-19 vaccine candidate JNJ-78436735. In September, Johnson & Johnson started Phase 3 clinical trials. The company hopes to file for emergency approval by early 2021.
Johnson & Johnson's competitors in the coronavirus vaccine race are Moderna and Pfizer. Moderna's and Pfizer’s COVID-19 vaccines will have a head start because they have completed Phase 3 clinical trials with an extremely strong outcome. Pfizer’s vaccine appears to be 95 percent effective in preventing the coronavirus, while Moderna’s vaccine is 94.5 percent effective. The companies will likely start shipping their vaccines in the next few weeks.
Johnson & Johnson’s COVD-19 vaccine progress
Johnson & Johnson expects to have all of the data required to file for U.S. emergency authorization for its experimental COVID-19 vaccine candidate by February 2021 or earlier. Johnson & Johnson's chief scientific officer, Dr. Paul Stoffels, said that the company expects to have nearly 60,000 people enrolled in a late-stage clinical trial, according to Reuters. He said, "An efficacy endpoint should be there in the first few weeks or months, January or February, of the new year."
Johnson & Johnson is several weeks behind some of its rivals in the global race to develop an effective vaccine against the coronavirus. So far, the COVID-19 pandemic has killed millions of people worldwide. In November, Moderna and Pfizer filed for emergency use authorization. However, Moderna's and Pfizer's vaccines are built on a two-dose model, while Johnson & Johnson’s experimental COVID-19 vaccine only requires one dose.
“In a pandemic a single shot is definitely important globally,” Stoffels said. “(A two-shot vaccine) is a very significant operational challenge. More so in healthcare systems which are less well organized.”
The distribution of Johnson & Johnson’s vaccine could be relatively seamless because the vaccine will likely remain stable for three months at refrigerator-like temperatures. In contrast, Pfizer’s vaccine requires specialized freezers. According to Forbes, Johnson & Johnson has priced its COVID-19 vaccine at $10 per dose, which is well below Moderna’s vaccine at $25–$37 per dose and Pfizer’s vaccine at $19 per dose.
Johnson & Johnson’s COVID-19 vaccine trial
The Phase 3 clinical trials for Johnson & Johnson started in September. However, the company had to pause the trial in October after one of the participants experienced a serious medical event. Johnson & Johnson resumed the trial after receiving the green light from an independent safety panel.
COVID-19 vaccine timeline
On Nov. 30, Moderna filed for an emergency use authorization request with the FDA for its experimental coronavirus vaccine candidate mRNA-1273. The company’s vaccine will be considered on Dec. 17 at the FDA's Vaccines and Related Biological Products Advisory Committee meeting. Moderna enrolled more than 30,000 volunteers in its Phase 3 clinical trials.
Pfizer has partnered with German company BioNTech to develop its COVID-19 vaccine. On Nov. 20, Pfizer filed for an emergency use authorization request with the FDA following favorable results from a completed Phase 3 trial. The agency has set a Dec. 10 deadline for the Vaccines and Related Biological Products Advisory Committee to review the emergency use authorization request.
AstraZeneca’s COVID-19 vaccine candidate could be up to 90 percent effective. The company will likely receive the results of its U.S. vaccine clinical trial in late-January and could potentially request an emergency use authorization.