April 16, 2021

The California Biotechnology Foundation is committed to keeping you up to date about COVID-19 testing, treatment and prevention advancements. The following resources track what progress has been made as of April 16, 2021. Notable advancements include:

• Pfizer has ramped up production of its two-shot COVID-19 vaccine and will be able to deliver a total of 300 million doses to the U.S. two weeks early and 10% more doses to the U.S. by the end of May.
• Regeneron Pharmaceuticals will ask the Food and Drug Administration to allow its COVID-19 antibody therapy to be used as a preventative treatment after a phase three clinical trial found the drug reduced the risk of symptomatic infections in individuals by 81%.
• Novartis will make ingredients for Roche’s Actemra treatment that is being repurposed for people with COVID-19 in Novartis’ third agreement after those with BioNTech and CureVac to make therapies for other firms to help fight the pandemic.

​Recent News:

• Stanford launches pediatric vaccine trial that will include children as young as 6 months
  ABC 30 – April 15, 2021
  As Americans continue to line up for COVID-19 vaccines, some California doctors are hoping to extend that option to younger children as well. Stanford is launching a pediatric vaccine trial that will ultimately include kids as young as 6 months.
• COVID-19 Disease Triggers More Ultra-Rare Blood Clots Than Vaccines, Study Finds
  Barron’s – April 15, 2021
  The risk of contracting blood clots is much higher for COVID-19 patients than from vaccines, according to a study. The rare blood clotting known as cerebral venous thrombosis, or CVT, occurred at a rate of 39 per million COVID-19 patients, according to researchers at the University of Oxford.
• Pfizer CEO says third COVID-19 vaccine dose likely needed within 12 months
  CNBC – April 15, 2021
  Pfizer CEO Albert Bourla said people will “likely” need a booster dose of a COVID-19 vaccine within 12 months of getting fully vaccinated and it’s possible people will need to get vaccinated against the coronavirus annually.
• What COVID-19 Variants Mean for Testing
  New York Times – April 14, 2021
  The Food and Drug Administration has warned that new mutations in the coronavirus could render some tests less effective. So far, scientists have agreed, there is no evidence that the known variants of concern are causing tests to fail completely. If variants begin to evade detection, that could be consequential not only for individual patients, who may not receive the treatment they need, but also for public health.
• Novartis agrees to make ingredients for Roche’s Actemra for COVID-19 patients
  Reuter’s – April 14, 2021
  Swiss drugmaker Novartis has signed a deal to make ingredients for Roche’s Actemra treatment that is being repurposed for people with COVID-19, the company said. The arrangement is the third transaction signed by Novartis following agreements with BioNTech and CureVac to make therapies for other firms to help fight the pandemic.
• Pfizer CEO says company can deliver 10% more doses to the U.S. by the end of May than previously agreed
  CNBC – April 13, 2021
  Pfizer CEO Albert Bourla said the company has ramped up production of its two-shot vaccine and will be able to deliver a total of 300 million doses to the U.S. two weeks early, in July. Bourla said Pfizer can deliver 10% more doses to the U.S. by the end of May than it had previously agreed to — up to 220 million from 200 million.
• NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins
  NIH – April 13, 2021
  A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
• Regeneron to request FDA clearance to use COVID-19 antibody drug as a preventative treatment
  CNBC – April 12, 2021
  Regeneron Pharmaceuticals said it will ask the Food and Drug Administration to allow its COVID-19 antibody therapy to be used as a preventative treatment. The therapy, has already been authorized by the FDA to treat adults with mild-to-moderate COVID-19 and pediatric patients at least 12 years of age who have tested positive for the virus and are at high risk of severe disease. Regeneron said it is seeking to expand the use of its treatment in the U.S. after a phase three clinical trial, jointly run by the National Institutes of Health, found the drug reduced the risk of symptomatic infections in individuals by 81%.
• Pfizer, BioNTech request expanded emergency use of COVID-19 vaccine for ages 12-15
  CNBC – April 9, 2021
  Pfizer and its German partner BioNTech said they have requested the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15. In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.

Rely on California Biotechnology Foundation to monitor breaking news and provide updates on the latest advancements in COVID-19 diagnostics, vaccines and treatments.

Stay informed on the latest news and trends on the economic and health benefits of this industry by visiting the new CABiotech.org

If you have any questions about informational briefings contact California Biotechnology Foundation Executive Director Patty Cooper at (916)764-2434 or [email protected].