A U.S. trial of a vaccine candidate could begin soon if regulation is eased on grounds of emergency as the two US based companies – Pfizer and BioNTech – are jointly developing the vaccine for US and Europe. They hope that it will be ready for use by the end of this year. Their first cohort of 12 participants received a dose of their vaccine candidate in the combined two phased clinical trial in Germany.
In addition to its efficacy, the vaccine’s safety and ability to empower the body’s immune response will be tested, as per varying dosages to 200 healthy volunteers, reported the CNN. The preliminary data could come as early as May or June, a Pfizer executive said on an investor call, mentioned the BioCentury. Pfizer has already started vaccine manufacturing and said on Tuesday in its quarterly report that it could supply millions of doses by year-end and scale up production to “hundreds of millions” in 2021. Meanwhile, Johnson & Johnson is also planning to start a trial of its prospective vaccine in September, with possible availability for emergency use in 2021.
The leading Oxford scientists began a Phase I clinical trial to test safety while injecting 1,100 people with a prospective vaccine. Next month, the sample will be broadened to include 5,000 to 6,000 volunteers. The next two phases will be conducted jointly to test efficacy and effectiveness of anti-COVID-19 vaccine. It is expected that if results come out to be promising and regulation procedures are carried on emergency basis, the vaccine could be available by September.
The director general of China’s Center for Disease Control and Prevention George Gao said that a vaccine from an unspecified Chinese entity could also be ready for emergency use but in special groups by September.