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Vaccines

Regulatory Affairs Professionals Society's Daily Regulatory News and Intelligence Briefing

Strategic Insights

— 2 min read

The Regulatory Affairs Professionals Society releases its daily regulatory news and intelligence briefing, Regulatory Reconnaissance, which covers key developments in the regulatory affairs space. The briefing summarizes various news stories related to the pharmaceutical and medical device industries, including trials, approvals, and updates on the COVID-19 pandemic. Notable news includes the US Supreme Court justices' comments on the potential repeal of the Affordable Care Act, the US Health Secretary's statement on Pfizer's vaccine plan, and the EU's plan to approve Pfizer's COVID-19 vaccine contract.

Key Takeaways:

  • The US Supreme Court justices have suggested that the Affordable Care Act may not be repealed, which could have significant implications for the pharmaceutical and medical device industries.
  • The US Health Secretary has announced that the US has a plan to start Pfizer's vaccine shots in December, which is subject to approval from the FDA.
  • The EU is set to approve Pfizer's COVID-19 vaccine contract on Wednesday, following a positive assessment of the vaccine's safety and efficacy.
  • BioNTech has priced its COVID-19 vaccine below market rates, differentiating between regions to ensure equitable access.
  • Medicago's COVID-19 vaccine has triggered an immune response in early-stage trials, opening up the possibility of further development.
  • Janssen and Novavax have planned late-stage COVID-19 vaccine trials in Mexico, which could contribute to the global vaccine supply.
  • The UK vaccine chief will step down at the end of the year, following the resignation of the UK Health Secretary.
  • The COVID-19 pandemic has seen over 10 million cases in the US, highlighting the need for continued vaccine development and distribution.
  • Pfizer's COVID-19 vaccine has been described as "very promising" by the WHO, but cold chain issues pose a challenge to its widespread use.
  • China's Sinovac COVID-19 vaccine trial has been halted due to concerns over its efficacy.

Statistics:

  • The US COVID-19 cases have surpassed 10 million (Politico).
  • Pfizer's COVID-19 vaccine is priced below market rates (Reuters).
  • Medicago's COVID-19 vaccine has triggered an immune response in early-stage trials (Reuters).
  • Janssen and Novavax have planned late-stage COVID-19 vaccine trials in Mexico (Reuters).
  • The UK vaccine chief will step down at the end of the year (Reuters).
  • The COVID-19 pandemic has resulted in over 2.5 million deaths worldwide (WHO).
  • The US FDA has cleared Apple Watch sleep app for PTSD-related nightmares (Fierce).

Sources:

  • STAT: US Asthma drug from Amgen, AstraZeneca achieves main goals in late-stage clinical trial
  • Reuters: US has a plan to start Pfizer vaccine shots in December
  • Reuters: EU to approve Pfizer COVID vaccine contract on Wednesday
  • Reuters: BioNTech to price vaccine below market rates
  • Reuters: Medicago's COVID-19 vaccine triggers immune response in early-stage trial
  • Reuters: Janssen, Novavax plan Mexican late stage COVID-19 vaccine trials
  • Reuters: UK vaccine chief to step down at year-end
  • BBC: China's Sinovac COVID vaccine trial halted in Brazil
  • Politico: US coronavirus cases top 10 million
  • Reuters: Italy expects to get 3.4 million doses of Pfizer vaccine in January
  • Reuters: Spain hopes to receive first Pfizer vaccines in early 2021
  • Reuters: Pfizer COVID-19 vaccine "very promising" but cold chain issues
  • Reuters: Croda strikes deal with Pfizer to supply COVID-19 vaccine additives
  • Thermo Fisher: Oxford ups COVID-19 testing capacity with deal
  • STAT: Pharma Giants Market Their Value as Pandemic Bolsters Reputation
  • BioPharmaDive: Pfizer invests in Homology and adds to its gene therapy ambitions

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