EU Considers Emergency Approvals To Boost COVID-19 Vaccine Rollout: Reuters

The European Commission is considering emergency approvals for COVID-19 vaccines as a faster alternative to lengthy conditional marketing authorizations used so far, reports Reuters.

• This potential change comes as the commission is under pressure for slow vaccine approvals contributing to a slower rollout of COVID-19 shots than the U.S. and Britain.
• The European Medicines Agency authorized the Pfizer Inc (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX) vaccine in late December 2020, weeks after receiving approval in the U.K. and the U.S.
• Also, for Johnson & Johnson (NYSE: JNJ) shot, the EU’s likely approval is on March 11, FDA approved the jab on February 28.
• One EU official said the emergency procedure had usually been used at the national level for terminally ill patients. The EU had instead chosen the lengthier conditional marketing authorization because with vaccines, “we inject healthy people” and the risk was disproportionate.
• The EMA has authorized three vaccines, including Pfizer/BioNTech, Oxford-AstraZeneca Plc (NYSE: AZN), and Moderna Inc (NASDAQ: MRNA), but EU countries can individually give emergency authorization to other shots.
• Along with sluggish take-up, the bloc is also facing supply and distribution issues, resulting in the disintegration of Europe’s unified vaccination strategy.
• According to data from the WHO, only 5.5% of the EU’s population have received a first shot of the approved vaccines.
• So now, some members are going outside the bloc in attempts to secure coronavirus vaccines. Leaders from Austria and Denmark will visit Israel this week to discuss future vaccine production and supply options.
• Other countries such as Slovakia and Hungary have turned to Russia and China, respectively, for shots that have not been approved in Europe.
• Slovakia’s approval for the Sputnik V vaccine is based on Russia’s trials and a comprehensive assessment of the vaccine by experts of the country.
• Earlier in February, Hungary began rolling out Sputnik V. Hungary is also the first EU country to have rolled out China’s Sinopharm vaccine, which the EMA has not approved.
• The fracturing of the EU’s centralized strategy comes amid an evolution within the bloc about the AstraZeneca vaccine.
• France recommended the AstraZeneca shot to anyone under 75 (up from a previous age limit of 65 years), including those with pre-existing health problems.
• According to a small study, the AstraZeneca-Oxford University or Pfizer/BioNTech effectively prevented COVID-19 infection, hospitalizations, and deaths.
• Price Action: MRNA shares are up 1.2% at $148.5, AZN is up 0.7% at 48.05, and PFE shares are up 0.8% at $33.77 in premarket on the last check Wednesday. JNJ shares closed 0.2% lower at $159.02, and BNTX dropped at $104.98, down 4.8% on Tuesday.