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By Laura Tucker, Staff writer; Image: Laboratory Research (Image source: Public domain)
There is so rarely any good news with the coronavirus pandemic, but to hear that a pharmaceutical company is planning human clinical trials of a vaccine for COVID-19 is very welcome news. That it won't begin until September is the bad news to go with the good.
Johnson & Johnson announced in a statement this week that its human clinical trials for a COVID-19 vaccine will begin in September, with the hopes of the first batches available for emergency use authorization by early 2021, which puts it on par for what we had been hearing, that vaccines wouldn't be available for a year to a year and a half.
The pharmaceutical company said it had been working on a vaccine since January. They are partnering with the Biomedical Advance Research and Development Authority, a division of the Department of Health and Human Services. The venture is committing $1 billion to fund the vaccine's research, development, and clinical testing.
"The world is facing an urgent public health crisis, and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible," said Alex Gorsky, Johnson & Johnson Chairman and CEO, in a news release.
The company is also expanding its global manufacturing capacity so that it can more quickly produce the vaccine, should it be approved.
Also working on a vaccine is Moderna, a biotech firm. The company already shipped its vaccine to government researchers in February, according to the National Institute of Allergy and Infectious Diseases. It was announced on March 16 that the first dose of the vaccine had been given to the first participant.
The goal of the study is to enroll a total of 45 healthy adults throughout a six-week period. Each of the 45 will receive two injections about a month apart in varying doses.
The hope for the Phase I trial is to prove that the vaccine is safe and that it will perform as expected on the immune systems of trial participants.
However, to prove that it's effective in preventing COVID-19, it will require follow-up studies with many more participants. Experts say this process will take many more months to complete the follow-up studies, which means it's probably not much further ahead than the Johnson & Johnson vaccine.
"Finding a safe and effective vaccine to prevent infection with [the novel coronavirus] is an urgent public health priority," said Dr. Anthony Fauci, the director of NIAID, in a statement at the start of Phase I, which is funded by NIAID. "The Phase 1 study, launched in record speed, is an important first step toward achieving that goal."
The vaccine uses messenger RNA, a genetic material, and was developed by NIAID in collaboration with Moderna. Credit for the speed of the Phase I trial was given to the agency's prior work on two other coronaviruses, SARS and MERS. The statement said the work on a MERS vaccine gave them a "head start for developing a vaccine candidate to protect against COVID-19."
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