Pfizer Inc PFE.N and BioNTech 22UAy.DE could get emergency USA and European approval for their COVID-19 vaccine in December after final trial results showed a resounding 95 per cent success rate without serious side effects, the drugmakers said on Wednesday, according to news agency Reuters.
Trials for another vaccine, developed by Oxford University and AstraZeneca, also show it safely produces a robust immune response in healthy older people, while producing fewer side effects than in younger people, its British maker said on Thursday.
The BioNTech/Pfizer shot and another one being developed by USA firm Moderna have taken the lead in the global chase for a vaccine, after large-scale trial data this month showed that their jabs were around 95 percent effective against COVID-19.
Out of 170 cases of covid-19 so far, 162 were in the placebo group - a strong signal the vaccine protected people.
He told AFP there is a chance they could receive the green light from the USA "this year", and even start delivering the vaccine by December.
"While the mortality rates remain low, some experts worry that a rise in cases among children may mean a rise in cases of Multisystem Inflammatory Syndrome in Children (MIS-C) later", says USA Today.
While mRNA technology has been around for decades, it has rushed to the front of the pack in the race to create a vaccine for a virus that disease scientists didn't know about at this time past year.
"We've seen people realize that the benefit of remdesivir is marginal at best - and the only benefit we had been touting was maybe it gets people better quicker".
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Dr. Theresa Tam said that the National Advisory Committee on Immunization (NACI) has provided preliminary guidance on key populations that should be considered for the first round of vaccines, including those at high risk of developing severe illness. Azar's office did not respond to requests for comment. "Once injected, the vaccines instruct cells to make copies of the coronavirus's spike protein, stimulating the creation of protective antibodies", says Bloomberg.
By the end of next year, Pfizer and BioNTech expect to make 1.3 billion doses, which would inoculate half as many people because each person needs to take two doses three weeks apart. Later, finalized results showed effectiveness to be closer to 95 percent.
Japan was also on "maximum alert" after logging a record 2,000 daily infections with almost 500 in the capital Tokyo alone, though no immediate restrictions were planned.
On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021.
The vaccine must be stored at minus 70 degrees Celsius, equivalent to minus 94 degrees Fahrenheit. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.
Given the urgency, the FDA is expected to move quickly. Final results and safety data are expected in the coming days or weeks. The most common reactions were that 3.7 percent of participants experiencing fatigue and 2 percent had a headache, it added. Johnson & Johnson said it is on track to deliver data this year. The FDA review process normally takes about six to 10 months, depending on the candidate's priority status.
Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials.
Moncef Slaoui, the scientific head of the United States government's Warp Speed programme to develop a vaccine, said he hoped the Pfizer/BioNTech jab would be approved as soon as next month.