COVID-19 VACCINE || Johnson & Johnson’s Single-Dose Vaccine Declared Safe And Effective
Johnson & Johnson’s single-dose COVID-19 vaccine is safe and effective in preventing disease.
The US Food and Drug Administration (FDA) said in a document released on its website that emergency use of the vaccine is likely to be approved soon.
The FD’s panel of independent experts will decide on February 26 whether to approve the use of the vaccine.
Although it is not necessary for the FDA to accept the opinions of experts, the recommendations are usually followed by the FDA.
Johnson & Johnson released the results of a third phase trial of the vaccine in late January , which found it to be 66% effective in preventing mild to severe illness, but the company said that Its effectiveness against was 85%.
The vaccine was 72 percent effective against mild and severe illness in the United States, 66 percent in Latin America and 57 percent in South Africa, the company said.
The company submitted data to the FDA, saying the vaccine was also effective in preventing asymptomatic cases.
According to the company, in a preliminary analysis of the trial, 16 asymptomatic cases were detected in the placebo group compared to the two groups using the vaccine, or its efficacy was 88%.
Although asymptomatic cases were not the main objective of the trial, the focus was on the prevention of mild to severe severity of COVID-19.
According to a document released by the FDA, this vaccine significantly reduces the risk of contracting the disease 14 days after vaccination.
Of the 44,000 people in the trial 14 days after the vaccine was administered, only two were diagnosed with a severe form of COVID-19, compared to 14 in the placebo group.
Twenty-eight days after the vaccine was administered, no one experienced a severe outbreak of COVID-19, compared to seven in the placebo group.
The three people in the trial experienced severe side effects from using the vaccine, but the FDA said the analysis did not reveal any risks to the vaccine’s safety.
The most common side effects were pain at the injection site (48.6%), headache (39%), fatigue (38.2%) and muscle aches (33.2%), the FDA said.
In one case, a type of heart disease was also discovered that may not have been the result of a vaccine, regulators said, but it was not immediately clear.
Other side effects included fever and high fever.
Johnson & Johnson had not previously released details of clinical trials other than vaccine efficacy rates.
The vaccine may be approved in the coming days, but many countries have already allocated large quantities for its production.
The United States has ordered 100 million doses, with additional options available.
The British government has bought 30 million food items while the European Union has bought 400 million food items.
The company has also agreed to provide 500 million doses to Kovacs, an agency set up by the United Nations to ensure the supply of vaccines to developing countries.
Originally published at https://zaviews.blogspot.com.