US FDA gives emergency use authorisation to COVID-19 vaccine from J&J
KV Prasad Jun 13, 2022, 06:35 AM IST (Published)
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Summary
In J&J’s 44,000-person global trial, the vaccine was found to be 66 percent effective at preventing moderate-to-severe COVID-19 four weeks after inoculation.
The US on Saturday got its third jab against the deadly coronavirus disease with the US Food and Drug Administration (USFDA) authorising a single-dose Johnson and Johnson anti-coronavirus vaccine for emergency use and setting the vaccine up for additional approvals around the world. President Joe Biden described the approval as an encouraging development in efforts to end the COVID-19 crisis and said this is exciting news for all US citizens.
The J&J vaccine is the third authorized in the United States, following ones from Pfizer/BioNTech and Moderna, both of which require two doses.
“Today, after a rigorous, open, and objective scientific review process, the Food and Drug Administration (FDA) issued an emergency use authorisation for a third safe and effective vaccine to help us defeat the COVID-19 pandemic – the Janssen COVID-19 (Johnson and Johnson) vaccine,” Biden said.
The EUA allows the Janssen COVID-19 vaccine to be distributed in the US for use in individuals of 18 years of age or older. Unlike the other two approved vaccines, the Johnson and Johnson vaccine is administered as a single dose.
The Pfizer and Moderna vaccines require two shots within two weeks.
“The authorisation of this (Johnson and Johnson) vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the US,” Acting FDA Commissioner Janet Woodcock said.
The FDA said the totality of available data provides clear evidence that the Janssen COVID-19 vaccine may be effective in preventing the infection.
Data also shows that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people of 18 years of age and older, it said.
“We know that more people that get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track,” President Biden said, adding that the country is moving in the right direction.
He said at the same time, this fight is far from over.
“Though we celebrate today’s news, I urge all Americans keep washing your hands, stay socially distanced, and keep wearing masks. As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse. My administration will not make the mistake of taking this threat lightly, or just assuming the best: that’s why we need the American Rescue Plan to keep this fight going in the months ahead,” Biden said.
There is light at the end of the tunnel, but people cannot let their guard down now or assume that victory is inevitable, the president said.
“We must continue to remain vigilant, act fast and aggressively, and look out for one another that is how we are going to reach that light together,” Biden said.
Congressman Frank Pallone, who is the chairman of the House Energy and Commerce Committee, said notably, this new vaccine is easier to store and transport than other COVID-19 vaccines and only requires one shot to protect patients.
“This will greatly improve our ability to protect millions of people against COVID-19 in communities across the country and is a giant step towards crushing the virus,” he said.
The authorisation of Johnson and Johnson’s COVID-19 vaccine brings the country another step closer to the light at the end of the tunnel, Pallone said.
Congressman Michael C Burgess, who is also a senior doctor, said that this is truly a remarkable achievement to see.
“To have three safe and effective vaccines not even a year from learning the virus sequencing is an outstanding accomplishment. This is a true testament to the dedication of American scientists and a shining example of American resourcefulness,” he said.
Earlier this week, an FDA panel released that Johnson and Johnson’s single-dose vaccine is effective for the coronavirus and its other severe forms, Burgess said.
“This third vaccine is a signal that we are nearing the end of this pandemic, but we cannot stop taking the proper precautions. Please continue to wash your hands thoroughly, wear a mask if you are unable to properly social distance, and stay home if you are sick. At the start of this pandemic, America declared that we are in this together and together we will reach the end,” he said.
In J&J’s 44,000-person global trial, the vaccine was found to be 66 percent effective at preventing moderate-to-severe COVID-19 four weeks after inoculation. It was 100 percent effective in preventing hospitalization and death due to the virus. There were very few serious side effects reported in the trial, which also offered preliminary evidence that the vaccine reduced asymptomatic infections.
J&J vaccine versus others
J&J’s vaccine is expected to be used widely around the globe because it can be shipped and stored at normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech SE and Moderna vaccines, which must be shipped frozen.
The U.S. government, which has purchased 100 million doses of the J&J vaccine, plans to distribute about 3 million to 4 million next week. That would be on top of the around 16 million doses of the Pfizer/BioNTech and Moderna vaccines the government already planned to ship across the country.
“We are ready to roll it out,” White House senior adviser Andy Slavitt wrote on Twitter after the authorization. Johnson & Johnson said it had begun shipping vaccines to the government.
J&J plans to provide a total of 20 million doses by the end of March, which along with the more than 220 million total doses expected from Pfizer and Moderna would be enough to fully vaccinate 130 million Americans.
So far, the United States has distributed more than 90 million doses of COVID-19 vaccines, some of which have been used for second shots. About 14 percent of Americans have received at least one dose, according to U.S. government data.
COVID-19 has claimed more than half a million lives in the United States, and states are clamoring for more doses to stem cases, hospitalizations, and deaths.
The J&J vaccine is also under review by the European Union, where deliveries are expected starting in April and would build on the region’s thin supplies of the Pfizer/BioNTech, Moderna and AstraZeneca Plc shots.
In South Africa, regulators were awaiting the FDA decision as their government looks to deploy more J&J vaccine against a variant of the virus called B.1.351 that is able to evade some vaccine protection.
J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response. J&J is testing a two-dose version of its vaccine, with results expected this summer.
—With inputs from agencies
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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow