In a report by the United States Food and Drug Administration (FDA), Johnson &Johnson’s one-shot vaccine appears to be safe and effective as per the present trial. The document about the effectiveness of the vaccine was published on Wednesday. Thus, the news paves way for the approval of the vaccine for emergency usage.
One-Shot Vaccine By Johnson & Johnson Is Quite Effective And Safe: FDA
The independent experts panel at FDA will meet on Friday to finally decide about the approval of the shot. While FDA is not bound by the advice of the experts, this time FDA has taken approval for the vaccine usage from Pfizer as well as Moderna. It’s a good news for Americans, as availability of vaccines by another manufacturer will make it easier and convenient for people to get vaccination quickly.
As per a report and document submitted by Johnson &Johnson to FDA, it said that the data suggests that the vaccine was quite effective at preventing asymptomatic infections. In the preliminary analysis of the trial, it has been found that 16 cases of asymptomatic cases in the placebo group versus the two in the vaccin group that vaccine has 88% efficacy rate.
Although asymptomatic infection was not the primary goal of the trial. It studies the vaccine’s ability to stop moderate to severe reduction in Covid-19 asymptomatic cases. Thus, the present trial results explain that the shot can reduce and cut the rate of transmission.
The Johnson &Johnson vaccine was 66% effective in prevention of Covid-19 and also against multiple other variants in the global trial of the vaccine. The trial was conducted on almost 44,000 people as per the reports by Johnson & Johnson.
The effectiveness of vaccines varied from one region to the other. The vaccine was effective for almost 72% in the United States. On the other hand, it was effective 66% in Latin America and 57% in South Africa. Overall, the Covid-19 vaccine was 85% effective in stopping the severe case.
As per the recent reports, the vaccine is quite effective in reducing the risk of Covid-19 and also in prevention of PCR-test confirmed Covid-19 at least 14-days after the vaccination. All this information was given by the FDA in its briefing document.
Fourteen days after the injection, only two vaccine recipients developed serious consequences and they had to get medical intervention. After 28-days of vaccination, no vaccine recipient developed COVID severe enough to require any type of medical intervention.
As per the analysis by FDA, no specific safety concerns have arisen in the trial of the Johnson & Johnson vaccine.
The most common adverse reaction was the injection site pain for almost 48.6% respondent, headache for 39% respondent, fatigue for 38.2% respondent and myalgia for 33.2% respondent.
Some of the additional side effects included fever in 9% of participants, and high fever in 0.2% of the respondents.
FDA also said that one case of pericarditis, which is a heart disease may also be caused by the vaccine. Johnson & Johnson has still not released any details of the clinical trial data other than the efficiency rate.