Johnson & Johnson has decided to move up it’s clinical trials by two months, from September to July, says the company as the pharmaceutical giant , like many others expects to be the first, in the race of creating ‘the’ vaccine,i.e COVID -19 vaccine.
The speeding up of the process will allow J&J to participate in the U.S. government’s proposed major clinical trials project which targets to provide an successful vaccine by the end of the year. In March, J&J signed agreements with the U.S. government to build adequate production resources to manufacture more than 1 billion doses of its vaccine by 2021, even before it has confirmation that the vaccine will be effective.
There are currently no recognized medications or vaccines approved for the virus in the USA. A vaccination is seen as necessary to end the pandemic that has affected more than 7.2 million people and killed more than 412,000 people across the globe and has also had an adverse affect on the several economies around the world .
“Based on the strength of the pre-clinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development,”Chief Scientific Officer Paul Stoffels of J&J said in a statement on Wednesday.
The trails by J&J will test the vaccine for safe operation and early signs of effectiveness in 1,045 healthy volunteers aged 18 to 55, and in those aged 65 and older. The trial will take place in the United States and Belgium.
The firm is also in discussions with the National Institutes of Allergy and Infectious Diseases (NIAID) to begin bigger, late-stage studies before time, based on early research outcomes and regulatory clearance.
The United States plans to study a number of participants for the coronavirus vaccine in studies that would involve up to 30,000 people and get a potency result as soon as possible. Health Chief of National Institutes Dr Francis Collins said.
Stoffels said last week that J&J hopes to have results of its vaccine efficacy trials in the first quarter of 2021. He added that the company is “working hard to bring it back to the end of the year.” A lot will depend on how much virus is circulating at that time, he said.
The company plans to test the vaccine in high-transmission regions within the United States. If the incidence is low, “we will complement that with international sites to make sure that we reach enough endpoints quickly to prove the vaccine works,” Stoffels said.
Moderna Inc, which is working in close partnership with NIAID, has started testing its vaccine candidate in a 600-subject mid-stage trial. The company expects to begin late-stage trials in July.
Moderna’s vaccine uses messenger RNA technology, an approach that has yet to produce any approved vaccines. J&J is utilizing the same technology used to make its Ebola vaccine, which won European regulatory approval late last month.
The trick with developing a vaccine is that it has to be widely tested and developed in a format that is effective on everyone and thus, can be mass-produced , so that the vaccine is profitable for the company manufacturing it too.
There are about 10 coronavirus vaccines in human testing. Experts have said a safe and effective vaccine could take at least 12 to 18 months from the start of development, which would shave several years off the typical vaccine development timeline.