The United States Food and Drug Administration has found the Johnsons & Johnsons vaccine effective against the COVID-19 infection. In a brief document, the FDA has said that the results of the third phase trials submitted by the drugmaker are promising and found to be safe and effective against the SARS-Cov2 infection.
Johnsons & Johnsons ongoing third phase trials are on completely randomized subjects, and they are also following the double-blind and placebo-controlled trials.
The company had applied for the emergency approval of the vaccine to the FDA on Feb 4. Now the FDA has said that the vaccine is safe and effective as per the reports presented by Johnsons & Johnsons. But a final decision on the single-shot vaccine will be out on Friday after discussing the matter with the FDA’s advisory committee.
Johnsons & Johnsons COVID-19 Vaccine Approved By FDA
FDA is not bound to follow the advice of the advisory committee. But as a standard procedure, the decision of approval will be decided in the meeting.
The Pfizer and Moderna vaccines have also gone through a similar procedure before the emergency approval of the COVID-19 shots.
The vaccine is named Ad26.COV2.S. It is made out of a stabilized variant of the SARS-Cov2 S protein. The vaccine is a replication-incompetent adenovirus type 26 known as (Ad26) vectored vaccine.
The documents said that the vaccine shows efficacy of 66.9% when cases are considered to occur 14 days after the single dose of the vaccination.
The efficacy is around 66.1% when cases are considered around 28 days of the vaccine dose. Vaccine efficacy against central laboratory has confirmed for the moderate, severe, and critical COVID-19 cases across all geographical areas in which the trial is conducted.
A trial that was conducted on about 44,000 people across the globe and against different variants of the coronavirus is known to be 66% effective, as claimed by the authorities at Johnsons & Johnsons.
The vaccine’s effectiveness was found to vary among different geographical locations. According to the report, the vaccine is about 72% effective in the US and 66% in Latin America.
The efficiency of the vaccine is the least in South Africa. But overall, the vaccine from Johnsons & Johnsons is found to be 85% effective in stopping severe cases of the COVID-19 infection.
The report also showed at least three cases with severe side effects after receiving the vaccine during the trials. But the FDA didn’t find any specific safety concerns that can preclude the issuance of the vaccine’s emergency use authorization.
After receiving approval from the advisory committee at FDA on Friday, the US is likely to get a third vaccine in the country within a year to curb the pandemic.
The authorization of the vaccine can be given as early as Saturday. Soon after the approval of the vaccine, the distribution of the vaccine can start within some days.
Since the vaccine developed by Johnsons and Johnsons is a single-shot vaccine, unlike the previously approved Pfizer and Moderna that require two shots a month apart, the number of fully vaccinated residents will increase rapidly with the distribution of the vaccine.
Again, the vaccine by Johnsons and Johnsons uses a sturdier virus for gene delivery into cells. This technique makes it possible to store the vaccine under normal refrigeration temperatures for about 3 months, ensuring an easy distribution to pharmacies and clinics to stock the doses.
Pfizer and Moderna vaccines use messenger RNA based technique to ask the body to generate antibodies. Their storage requires temperatures to be as low as -72 ⁰C.
Till now, around 40 million Americans are vaccinated with the two vaccines. But only 20 million has received both the shots. With the newly developed vaccine, if approved, the pace of full vaccination will surely increase.