Oxford scientists expect COVID-19 vaccine data by Christmas

Laverne Higgins
November 20, 2020

Pfizer announced Wednesday their vaccine has an efficacy rate of 95 per cent and will be seeking approval "within days" from US regulators to allow emergency use of the vaccine.

Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5% effective after an interim analysis of its late-stage study.

The companies said they "plan to submit a request within days" for an emergency use authorization based on the totality of safety and efficacy data collected to date, and plan to share the data with other regulatory agencies around the world. Now we've got to get the data about the vaccines in front of regulators for them to scrutinize it and approve the first vaccines.

"Because of this work, by the end of December we expect to have about 40 million doses of these two vaccines available for distribution pending FDA authorization", said Azar.

Similar results from two vaccines both made with a brand-new technology - using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along - likely will add to experts' reassurance about the novel approach.

Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those people's ages. In the new written release, Pfizer said its full data report involved more than 43,000 study participants and logged 170 cases of COVID-19-162 of which occurred among people receiving the placebo shot.

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people. Out of 10 cases of severe COVID-19, nine had received a placebo.

"The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2", the companies said. Two percent of volunteers reported a headache after the second dose.

First doses of China's CoronaVac COVID-19 vaccine arrive in Brazil
The Phase 3 trials of the vaccine are underway and early efficacy readings could come out in the upcoming weeks. They show that older adults aged 56-69 and over 70 had a similar immune response to younger adults aged 18-55.

German Chancellor Angela Merkel, a former scientist who has been praised for her handling of the coronavirus crisis so far, on Thursday said "we don't want to take any risks" on a vaccine, and that the latest news was encouraging.

Pfizer and BioNTech's trial included almost 44,000 volunteers, half of whom received the vaccine.

All COVID-19 vaccines will need to be approved by Health Canada before they are distributed.

That means that initially, doses will be limited and until researchers learn more about how long the vaccine-induced protection against the COVID-19 virus lasts, we will still be wearing masks, washing our hands frequently, and social distancing to curb spread of the virus.

The department is now reviewing some of Pfizer's Phase 3 clinical data, which it received earlier, Sharma said. All three require would require an individual to get two doses of the vaccine, several weeks apart.

Americans will receive the vaccine for free, under a $1.95 billion deal the federal government reached with Pfizer for 100 million doses.

The Pfizer vaccine must be stored at about minus 80C, although it can be kept in a fridge for five days.

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