Healthcare Roundup – EU regulator remains undecided on Moderna’s COVID-19 jab; U.K. rolls out AstraZeneca-Oxford’s COVID-19 vaccine

Published on: January 4, 2021
Author: Amy Liu

EU regulator remains undecided on Moderna’s COVID-19 jab

  • The European Medicines Agency has yet to finalize a decision on the approval for the COVID-19 vaccine from (MRNA +5.9%) as discussions have ended without a conclusion, according to the Dutch national medicines authority.
  • Earlier, the EMA’s human medicines committee had arranged an unscheduled meeting Monday afternoon to discuss the vaccine.
  • An approval decision could still follow at the meeting on Wednesday, Reuters quoted the Dutch medicines regulator, CBG as saying.
  • The Amsterdam-based agency had earlier moved forward the meeting to discuss the authorization for Moderna’s vaccine to January 06 from January 12. The EU cleared the Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX)vaccine on December 21, two days before the previously-scheduled meeting.

U.K. rolls out AstraZeneca-Oxford’s COVID-19 vaccine – CNBC

  • Britain began rolling out the coronavirus vaccine developed by AstraZeneca (NASDAQ:AZNand the University of Oxford – CNBC.
  • The 82-year-old Brian Pinker was the first person in the world to receive the jab, after it was approved for use by U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) last week.
  • The AstraZeneca-Oxford vaccine is seen as a game-changer because it does not require very cold temperatures for storage like the ones from Pfizer (NYSE:PFE) – BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA).
  • In a statement Monday, the U.K. government said that more than half a million doses are now available “with tens of millions more to be delivered in the coming weeks and months once batches have been quality checked by the MHRA.”
  • As with the Pfizer vaccine, the AstraZeneca-Oxford shot will be given to priority groups first, including care home residents and staff, people aged over 80 and health and care workers, then to the rest of the population.
  • On Jan. 1, The Times newspaper reported that the drug manufacturer would boost production so that 2M jabs would be made each week by mid-January.

Tiziana Life completes Brazilian study of nasally administered foralumab in COVID-19

  • Tiziana Life Sciences (NASDAQ:TLSA) has completed its clinical study in Brazil investigating nasally administered Foralumab, either alone or in combination with orally administered dexamethasone in COVID-19 patients.
  • Topline data are expected in January. The last patients in the trial received final dose on December 21, 2020.
  • The study enrolled a total of 39 patients. The primary endpoint was safety of the treatment, and secondary endpoints were to evaluate the effect on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression.
  • Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated.
  • In November 2020, the company launched foralumab study for COVID-19 in Brazil.

Ocumension Therapeutics invests $15.7M in EyePoint Pharma

  • EyePoint Pharmaceuticals (NASDAQ:EYPT) announces that China-based Ocumension Therapeutics has made a $15.7M equity investment in the company.
  • Under the terms of the agreement, Ocumension has purchased ~3.01M shares of EyePoint’s common stock at ~$5.22/share.
  • “This investment underscores our continued strong partnership with Ocumension for YUTIQ and DEXYCU in Asia,” said Nancy Lurker, President and CEO of EyePoint Pharma. “We are excited about the significant potential of these products in both the U.S. and in Asia and for our R&D pipeline, including the Phase 1 trial of EYP-1901 in wet age-related macular degeneration that is expected to commence in the coming months.”
  • Estimated cash and equivalents of ~$44M as on December 31, 2020, combined with cash inflows from product sales are expected to fund the company’s operating plan into H2 2021.
  • Last month, EYPT’s wet AMD candidate, EYP-1901 showed encouraging action in animal study.

Moderna’s COVID-19 vaccine dose could be cut in half to speed up rollout

  • The officials of Operation Warp Speed are in discussion with the FDA and Moderna (MRNA +6.3%) to explore the possibility of halving the company’s COVID-19 shot to some individuals in the U.S. as the country attempts to accelerate the vaccine rollout.
  • On CBS’ “Face the Nation”, Moncef Slaoui, the head of Operation Warp Speed said that giving half the dose for people between the ages of 18 to 55 could achieve “identical immune response” to the one hundred microgram dose tested in Phase 3 clinical trial run by the company.
  • Calling the initiative as a ‘way to speed up immunizations against Covid-19,’ he, however, cautioned that a decision not supported by trial data will be a mistake, adding “Ultimately it will be an FDA decision.”
  • With a similar view, White House health advisor, Dr. Anthony Fauci has highlighted the importance of expediting the vaccination drive. Dr. Fauci termed the plan as ‘the right solution to the wrong problem,’ arguing that not having enough vaccines was not the issue at hand.
  • Meanwhile, facing a surge in infections, the health authorities in the U.K. have tweaked the COVID-19 vaccine guidelines, raising concerns among health experts.

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