New Johnson & Johnson Single Dose Vaccine Developed, on its Way to FDA’s Approval
Updated: Oct 16, 2021
Ola Chaic
On Wednesday, Feb. 24, an analysis concerning the Johnson & Johnson (J&J) single-dose COVID-19 vaccine revealed that it offers strong protection against more severe forms of the virus. The United States Food and Drug Administration (FDA) scientists have confirmed that the vaccine is safe, with an overall 66% efficacy rate in preventing moderate-to-severe COVID-19 cases, and is 85% effective against the most serious forms. However, the analysis is only one step in the evaluation process. On Friday, the FDA’s independent advisors will debate if there is enough evidence to corroborate its potency.
The development of a third and potentially more effective vaccine is especially important as the death toll in the U.S.continues to rise. Just two days ago, the U.S surpassed 500,000 deaths caused by the virus. Additionally, the vaccine roll-outs are being hampered by logistical and weather-based interference.
J&J performed tests, distributing their single-dose option to 44,000 adults in the U.S., Latin America, and South Africa, with a 72%, 66%, and 57% respective efficacy rate, against moderate-to-severe COVID-19 cases.
South Africa recently began distributing the J&J vaccine to front-line healthcare workers on a test basis after deciding that the vaccine from AstraZeneca was not shown to be as effective as the latter.
The FDA also mentioned that the safety and effectiveness of this vaccine were consistent across racial groups. The vaccine was administered to participants across the racial spectrum, including Black and Latino individuals, and resulted in no adverse side-effects. However, the FDA cautioned that, given that there are multiple strains of the virus circulating in the aforementioned countries, the results may be unclear on yielding pertinent information concerning the vaccine’s potency. Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, when asked about the information concerning the different variants of the virus and the vaccine, said that she was “reassured” and that the information provided by J&J was “pretty robust”.
Wednesday’s analysis showed the protection of the J&J vaccines emerged after 14 days of vaccination across all countries. By 28 days, there were no hospitalizations or deaths in the vaccinated groups.
Another advantage of the J&J vaccine is that it does not need to be frozen, unlike the vaccines offered by Moderna and Pfizer. This development will make it easier to transport and store the vaccine, as both Moderna’s and Pfizer’s vaccines have to be transported and stored in refrigeration units kept at a specific temperature. The FDA’s approval of this vaccine will not immediately boost vaccine supplies; only a few million are ready for shipment. Both European regulators and the World Health Organization are considering J&J’s vaccines. The company aims to produce a billion doses by the end of the year.