An ad for COVID-19 testing reflects on glass at a bus stop, as pedestrians walk past Pfizer world headquarters in New York. File / AP
Pfizer on Friday announced that it is moving ahead with its request of asking the US regulators to allow emergency use of its COVID-19 vaccine, which has shown 95 per cent efficacy in a totality of two data sets released in the last 10 days
Unless some nasty surprises turn up, Pfizer's action on Friday could be the first step towards vaccinating the most vulnerable Americans by December end.
"Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," Pfizer CEO Albert Bourla said.
The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said.
"The companies will be ready to distribute the vaccine candidate within hours after authorisation," their statement said.
The Food and Drug Administration has not said how long it will take to study the vaccine data, but the government expects to give the green light for the vaccine in the first two weeks of December.
Pfizer and another US company, Moderna, have broken all vaccine development speed records in their race for a cure over the last nine months.
US regulators are standing by for the approval process while coronavirus cases are surging to record levels across all the 50 states. Pfizer's submission also includes safety data on approximately 100 children aged 12-15 years.
The European Union could also move quickly on the Pfizer-BioNTech vaccine, perhaps as soon as the second half of December, according to European Commission president Ursula von der Leyen.
Hot on the heels of these companies is a vaccine developed by another biotech firm, Moderna, which says its product is also about 95 percent effective.
The US government says it plans to vaccinate more than 20 million people in December, and then another 25-30 million per month.
Adding to the encouraging 95 per cent efficiency data for the Pfizer product is the fact that efficacy was found to be consistent across all age-groups — a primary concern for a disease that hits the elderly the hardest — as well as genders and ethnicities.
Pfizer and BioNTech say 170 people fell sick in an ongoing clinical trial of almost 44,000 people — 162 of whom were in a placebo group and eight of whom received the two-dose medicine.
Out of the 170 patients who became sick, 10 developed severe COVID-19 — nine in the placebo group and one in the vaccine group.
The new data showed the vaccine was generally well tolerated, with most side-effects short-lived and either mild or moderate.
About four percent experienced severe fatigue and two percent got severe headaches after their second dose. Older patients had fewer and milder side-effects.
The new US study will include up to 1,420 volunteers ages 18 to 55 to test the updated Omicron-based shots for use as a booster or for primary vaccinations. Researchers will examine the tweaked vaccine’s safety and how it revs up the immune system...
The vaccine, called AZD1222, has been described by the World Health Organisation's chief scientist as the leading candidate in a global race to halt a pandemic that has claimed more than 600,000 lives.
African-American communities nationwide have seen disproportionately high levels of death and illness related to the COVID-19 pandemic, while polls have also indicated they are among the most reluctant to get vaccinated.
An unrelenting US coronavirus surge pushed besieged hospitals further to the brink as the United States pressed on with its immunisation rollout on Thursday and prepared to ship nearly 6 million doses of a new vaccine on the cusp of winning regulatory approval.
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