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COVID-19 Updates EU, UK and US

global covid pharma drug safety

COVID-19 Updates | EU, UK and US

More European countries announced restrictions this past week, in an attempt to limit the spread of the virus.  Portugal and Austria imposed a partial lockdown in most of their territories, Italy added four regions on lockdown, including Lombardy, while Greece imposed a national lockdown from 7 November.  As European countries enter a second phase of lockdown, social unrest has increased throughout Europe, with protests in Rome, Milan and NaplesMadridBarcelonaBrussels and Berlin.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee announced on 20 October that it has reviewed guidance on how to prepare risk management plans for COVID-19 vaccines.  The guidance is expected to supplement the existing guidance on risk management plans for medicines and is now being consulted by the EMA’s Human Medicines Committee for adoption.

Although there was positive developments for the EU economy in the summer with the COVID-19 pandemic under control, the European Commission predicted a grim growth forecast for 2021.  In its Autumn 2020 economic forecast, the European Commission predicted a growth of 4.2% in 2021 and expected the EU’s economy to shrink by 7.8%.  Unemployment rates are expected to increase at 9.4%.  According to the Commissioner for Economy, Paolo Gentiloni,

Growth will return in 2021 but it will be two years until the European economy comes close to regaining its pre-pandemic level.  In the current context of very high uncertainty, national economic and fiscal policies must remain supportive, while NextGenerationEU must be finalised this year and effectively rolled out in the first half of 2021.”

Negotiations of the Recovery and Resolution Regulation, the main instrument that would facilitate the payment of the loans and grants to Member States in the context of COVID-19 recovery, are expected to progress next week, as the European Parliament is expected to adopt its negotiating mandate to proceed to inter-institutional negotiations with the Council and the European Commission.

On Thursday, 5 November, UK Prime Minister Boris Johnson provided an update on efforts “to put the coronavirus back in its box.”  Recognizing travel implications with the upcoming Christmas holiday, he stated,

The UK Government and the devolved administrations are working together on a joint approach to the Christmas period, because all of us want to ensure families can come together wherever they live.”

Of tight, four week restrictions imposed across England, he reminded they will expire on 2 December and a tiered approach would be reinstated.  Meanwhile, Wales ended a two week “firebreak” lockdown and reverted to a lesser set of restrictions.

The United States hit a new high of daily reported COVID-19 infections (121,054) this past week.  On Thursday, the Centers for Disease Control and Prevention (“CDC”) released a forecast suggesting the United States could reach 266,000 COVID-related deaths by the end of November.  State and local governments have control over imposing restrictions across the country, with some jurisdictions announcing stay-at-home orders and other seeking more strict lockdowns, which will likely frustrate some Thanksgiving Holiday plans later this month.

Meanwhile, on Thursday, 5 November, the United Nations voted 150-0 to hold a COVID-19 Pandemic Summit on 3-4 December.  The United States, Israel and Armenia abstained voting on a resolution – led by Canada and Azerbaijan – that authorized the Summit and spelled out arrangements, such as prerecorded speeches by world leaders and a discussion led by World Health Organization Chief Tedros Adhanom Ghebreyesus.  The US abstention explanation is available here.

On Monday, 9 November, Pfizer and German-based BioNTech released interim data from the advanced, large-scale clinical trials of its COVID-19 vaccine (BNT162b2), noting it is more than 90% effective.  Next steps, full trial data will be released and peer-reviewed or published in a medical journal.  The companies can also seek US Food & Drug Administration authorization this month for emergency use of the vaccine; a regulatory decision could be forthcoming as soon as December.  Pfizer/BioNTech estimate they can produce up to 50 million doses this year, which could protect 25 million people.  In 2021, they anticipate producing up to 1.3 billion doses.  President Trump responded to the news on Twitter, noting,

STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”

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