American medical device and pharmaceutical corporation, Johnson & Johnson, has completed the phase three trial for the company’s COVID-19 vaccine. The company on Friday said it would be going to the Food and Drug Administration (FDA) next week to apply for an Emergency Use Authorization (EUA), just like Moderna and Pfizer did last year after completing their Phase 3 trials.
Upon success, the vaccine will be joining the two vaccines that have been approved for EUA in the United States. The EUA will drastically cut back the time it takes to approve the vaccine for public use as a result of the urgent need for it.
According to Johnson & Johnson, the outcome of the worldwide study indicates that the vaccine has 66% effectiveness against medium and severe infections and 85% effectiveness against severe infections. The trial carried out in the US shows that the vaccine is 72% powerful against both levels of infections.
Though not as potent as the Pfizer and Moderna coronavirus vaccines which have over 90% potency against medium and severe infections, the single-dose vaccine will serve as an additional option for Americans who are still undecided about the COVID-19 vaccine to choose. It will also help the US and other countries to fight the COVID-19 pandemic.
Top American immunologist, Dr. Anthony Fauci, applauded the company for the feat, noting that the vaccine will help to gradually return the condition in hospitals and other health care facilities to how they were before the coronavirus pandemic.
“The vaccine and others before it will help reduce the burden that the pandemic has placed on our health care sector,” Fauci stated on Friday. “It is extremely crucial for us all that that burden is lifted off the sector, and this can only happen if a reasonable number of our population is inoculated against the virus.”
The single-dose vaccine has different success rates in different regions, Johnson & Johnson said, adding that it recorded one of the vaccine’s lowest figures in the trial that took place in South Africa with only 57% potency, NY Times writes. The reason for the low result is the mutated version of the coronavirus that was discovered in the country. The strain is 50% more easily contracted than the original strain and scientists have revealed that known vaccines will have less potency against it.
Dr. Mathai Mammen, one of the global top execs of the company, stated that the company’s vaccine has proven itself useful against severe infections from all strains of the virus and for people of all ages. He said with 85% effectiveness against severe infections, the vaccine will go a long way in helping to end the coronavirus pandemic.
The trial for the vaccine was conducted in 8 countries and over 44,000 people participated. The company said that at the end of the trial, 468 out of those that received the vaccine and a placebo tested positive for the virus. It added that it is going to publish the result in the next few weeks. It is also going to apply for a EUA next week. Mammen told reporters that before the end of next month, the company expects the FDA to approve its EUA application.
Source: cnn.com