Updated: Nov 12, 2020
NEW BRUNSWICK, N.J. -- On Wednesday, September 23rd, New Jersey based Johnson& Johnson announced that it would be launching its first large-scale, multi-country Phase 3 trial of it’s single-shot Coronavirus vaccine.
Johnson & Johnson joins three other companies to move into Phase 3 of testing. Consequently, the pharmaceutical company will begin testing their vaccine in approximately 60,000 volunteers, across three continents, becoming the first single-shot vaccine trial to move into Phase 3 in the United States.
In a press release released on their website, Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson stated, “We remain fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world.”
Additionally, Johnson & Johnson also asserted that it is committed to transparency. Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson asserted, “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
The New Jersey based company claimed that their single-dose vaccine “could be a very efficient tool to combat the pandemic as it is faster acting.” Johnson & Johnson also stated that animal models and early human studies show that their vaccine generated a strong immune response in approximately fifteen days. Johnson & Johnson says that should enrollment go as expected the trial could provide results by the end of the year.
United States health Officials also have assured Americans that a vaccine will not be approved until it is proven safe and effective. At a senate committee meeting on Wednesday, Dr. Anthony Fauci said, “We predict that sometime by the end of this year, let's say November or December, we will know whether or not these are safe and effective. Early studies in animals and in human Phase 1 and Phase 2 indicate that individuals induce a response that is comparable to, if not better, than natural infection, Right now, doses of this vaccine are being produced so they'll be ready to be distributed.”
Dr. Fauci did however, assert that the probability of a vaccine being available by election day as “unlikely” although not “impossible.” In contrast to Dr. Fauci, President Trump continues to insist that a COVID-19 vaccine is on its way. In press conference on Wednesday the President claimed that the White House could override FDA authorization, stating that he will push for an authorization by election day.