New Brunswick drugmaker Johnson & Johnson announced Thursday, Feb. 4 that it applied for emergency federal authorization of its COVID-19 vaccine candidate, with approval from the Biden administration almost certain.
Johnson & Johnson announced on Jan. 29 that its single-shot vaccine candidate was 66% effective in preventing moderate and severe forms of the illness, making it the third drugmaker to develop a vaccine behind Pfizer and Moderna, and the first in New Jersey.
Storage requirements for the Johnson & Johnson shots are far less onerous than the Arctic-level temperatures needed for Moderna and Pfizer. Instead, Johnson & Johnson’s vaccines can be kept between 36 and 46 degrees Fahrenheit.
The federal Food and Drug Administration will meet on Feb. 26 to discuss emergency approval.
Performance was stronger in the United States and weaker elsewhere in the world, based on data from the company’s Phase 3 trial, according to the late-January announcement. It was 72% effective against moderate and severe forms of the illness in the United States, Johnson & Johnson said.
Additionally, Johnson & Johnson stated the candidate was 85% effective four weeks after vaccination in adults in preventing COVID-19 infections severe enough to require hospitalizations.
“The ability to avoid hospitalizations and deaths would change the game in combating the pandemic,” Mathai Mammen, who heads research and development at Janssen, the vaccine research arm of Johnson & Johnson, said on Jan. 29.
Johnson & Johnson on Thursday said it expects to ship 100 million doses across the U.S. by the middle of 2021.
Paul Stoffels, the chief scientific officer for Johnson & Johnson, called the single-shot dose a “pivotal step toward” national and global vaccination efforts.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Stoffels added. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
While the national and state efforts to roll out the COVID-19 vaccine have been plagued with delays, bureaucratic headaches and severe shortage of doses, public health officials have assured that an increased presence of doses will smooth out the supply-demand imbalance.
There are six other pharmaceutical companies trying to develop the vaccine, including Sanofi which is based in Bridgewater. Kenilworth-based Merck scrapped its vaccine plans after reporting lackluster data during Phase 1 trials.