Regulator formally asked to assess Oxford University and AstraZeneca vaccine

A coronavirus vaccine rollout in the UK could be a step closer after the regulator was formally asked by the Government to assess the Oxford University and AstraZeneca jab.

The move “marks a significant first step in getting the vaccine approved for deployment” if it meets safety, efficacy and quality standards, the Department of Health and Social Care (DHSC) said.



It comes a week after the Medicines and Healthcare products Regulatory Agency (MHRA) was formally asked by the Government to assess the Pfizer/BioNTech vaccine.

Health Secretary Matt Hancock said: “We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator the MHRA.

(PA Graphics)
(PA Graphics)

“We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards.”

British scientists have defended Oxford University and AstraZeneca after questions were raised about the results of their vaccine trial.

AstraZeneca said it will most likely carry out a further global clinical trial to assess the efficacy of the jab after a surprise result found 90% protection was achieved when people were given a half dose followed by a full dose.

The pharmaceutical giant has acknowledged the finding was as a result of a dosing error, but said it did not expect any new trial to delay regulatory approval in countries including the UK.

US scientists questioned a lack of detail in the trial results published last week, and the scientific head of the US’s Operation Warp Speed – the programme to supply America with vaccines – told US reporters the half-dose regime was only given to people aged 55 and under.

Scientists across the globe are hoping to find vaccines that work in older people – the group who are most at risk from Covid-19.

Helen Fletcher, professor of immunology at London School of Hygiene and Tropical Medicine (LSHTM), said of the Oxford/AstraZeneca vaccine: “It’s not surprising if some manufacturing issues were still being ironed out when they started clinical trials but early stage trials are all about safety and the safety data we have seen has been very robust.”

She said it was important to wait for the full dataset to be published.

Stephen Evans, professor of pharmacoepidemiology at LSHTM, said: “The way the data are put together will have been specified in the protocol and scrutinised very carefully by regulators to ensure that there is no ‘cherry picking’ of the results.”

The DHSC said the MHRA has already started a “rolling review” of the Oxford/AstraZeneca vaccine and that once the regulator receives the full safety, efficacy and quality data from the company, its scientists and clinicians “stand ready to progress its assessment of the vaccine”.

The Government said it has secured access to 100 million doses of the Oxford/AstraZeneca jab and 40 million of the Pfizer/BioNTech vaccine.

If approved, a vaccine could be rolled out from December, Mr Hancock has said.

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Michigan formally certified its Electoral College votes for Biden, another blow to Trump’s attempt to overturn the election results



a car parked in a parking lot: Motorists participate during a drive-by rally to certify the presidential election results near the Capitol building in Lansing. Paul Sancya/AP


© Paul Sancya/AP
Motorists participate during a drive-by rally to certify the presidential election results near the Capitol building in Lansing. Paul Sancya/AP

  • Michigan’s four-member Board of State Canvassers voted on Monday to formally certify the state’s 16 Electoral College votes for President-elect Joe Biden.
  • Democrats Jeanette Bradshaw and Julie Matuzak and Republican Aaron Van Langevelde voted to certify, while Republican Norman Shinkle abstained. 
  • The board heard over three hours of testimony and public comments from current and former election officials, party officials, and members of the public before taking a vote on certification. 
  • Michigan’s statewide certification marks the president’s latest failure in overturning his electoral defeat.
  • Visit Business Insider’s homepage for more stories.

Michigan’s four-member Board of State Canvassers voted on Monday to formally certify the state’s 16 Electoral College votes for President-elect Joe Biden, marking President Donald Trump’s latest failure overturn election results in key states. 

Biden won Michigan by 156,643 votes — a margin of 2.8 percentage points — over Trump, according to Decision Desk HQ. That result far surpasses the 10,704 vote margin by which Trump carried Michigan in 2016. 

After hearing over three hours of testimony from election and campaign officials, and members of the public, three members of the board — the minimum threshold required – voted to certify the results.

Both Democratic board members, Chairwoman Jeanette Bradshaw and Julie Matuzak, as well as Republican Aaron Van Langevelde voted in favor of certification. Republican Norman Shinkle abstained.

If the board had deadlocked along partisan lines, the matter would have immediately gone to the courts, which could then have ordered the board to certify the results, CNN reported.

A number of current and former election officials, including former state elections director Chris Thomas, former Detroit elections director Daniel Baxter, and former Board of State Canvassers member Jeff Timmer, testified in support of the board certifying the election.

Video: Wayne County Board of Canvassers member, “I’m confident that the election will be certified” (MSNBC)

Wayne County Board of Canvassers member, “I’m confident that the election will be certified”

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Current officials who were in favor of the move included the state’s Bureau of Elections director Jonathan Brater, Detriot City Clerk Janice Winfrey, Lansing City Clerk Chris Swope, Ingraham County Clerk Barb Byrum, and Livonia City Clerk Susan Nash. 

Laura Cox, representing the state Republican Party, and former GOP Senate candidate John James’ attorney, Charles Spies, testified in opposition and asked the board to delay certification pending further review of what they described as abnormalities in reporting of votes and exclusion of Republican poll observers. 

Van Langevelde appeared skeptical of arguments from GOP lawyers that the law gives the Board of State Canvassers authority to independently request audits and further review the results of the election before certification. A candidate can only request a recount after certification. 

“We can agree to disagree, but I think the law is on my side here,” Van Langevelde told Spiers, the James’ campaign lawyer. “Our duty

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