The EU Is Preparing to Launch Legal Proceedings Against Vaccine Producer AstraZeneca Over Vaccine Shortfalls

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The European Union and pharmaceutical giant AstraZeneca have had a rough vaccine rollout, and many are complaining that regulators were too slow to approve the shots. AstraZeneca repeatedly slashed its delivery commitments, telling the public that they could not deliver as many vaccines as the bloc was counting on, which has led to delays in the COVID-19 vaccine in 27 EU nations. 

The European Commission raised the matter at a meeting of EU ambassadors Wednesday, during which the majority of EU countries said they would support suing the company on the grounds that it massively under-delivered pledged coronavirus vaccine doses to the bloc. However, five to six countries have raised concerns about launching a lawsuit against AstraZeneca, saying that the lawsuit wouldn’t guarantee that the EU got more doses. 

Some ambassadors also felt that launching a lawsuit would damage the image of AstraZeneca, diminishing citizens’ trust in the vaccine. In March, European Commission President Ursula von der Leyen had expressed disappointment with AstraZeneca during a press conference, saying that “AstraZeneca has unfortunately under-produced and under-delivered. And this painfully, of course, reduced the speed of the vaccination campaign.” AstraZeneca’s CEO Pascal Soriot had told EU lawmakers in February that low yields at EU production plants were causing the delays. 

EU countries also discussed on Wednesday contracts for more EU vaccines, following the Commission’s announcement last week that the EU secured 1.8 billion BioNTech/Pfizer vaccines through 2023. According to a diplomat, some ambassadors worried that the EU essentially is giving Pfizer a “monopoly” and said the EU needs to have a broad portfolio of vaccines. 

A spokesman for AstraZeneca said the company was not aware of any legal proceedings "and continues to hold regular discussions on supply with the commission and member states.” The EU has also decided not to take up an option to buy 100 million extra doses of AstraZeneca under the contract, after safety concerns about very rare cases of blood clots linked to the vaccine as well as supply delays.

Can Businesses and Companies Require a COVID-19 Vaccine In The Workspace? What EEOC and OSHA Recommends

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The Food and Drug Administration (FDA) has received two major applications from several pharmaceutical companies for emergency use authorization of a COVID-19 vaccine. The vaccine testing process includes:

  • Preclinical testing

  • Phase 1 safety trials

  • Phase 2 expanded trials

  • Phase 3 efficacy trials

  • Early or limited approval

  • Approval

Many companies are getting approved for emergency use authorization in different countries and are in their final testing phase, such as the New York-based Pfizer and German company BioNTech. On December 8th, the FDA released that their specific vaccine has an efficacy rate of 95%, and these preliminary results have led to authorizations across the world. The United Kingdom became the first Western country to approve the coronavirus vaccine for emergency use with injections beginning on December 8th and December 9th for Canada. 

As Pfizer, Moderna, and AstraZeneca are all finishing up testing in their final phases, employers will need to decide whether they can direct employees to get a vaccine as a requirement before returning to work. While the U.S. Equal Employment Opportunity Commission (EEOC) has not provided official guidelines for the COVID-19 vaccine yet, they have updated their Pandemic Preparedness for the Workplace guidance, issued in 2009 in response to the H1N1 outbreak. The update suggests employers and employees follow guidance from the Centers for Disease Control and Prevention (CDC) and state/local public health authorities to slow the spread of the disease and protect workers, clients, and the public. In addition, the EEOC has declared that COVID-19 meets the ADA’s “direct threat standard,” which permits employers to engage in broader procedures than generally allowed under the ADA. The Occupational Safety and Health Administration (OSHA) has also not released official guidelines related to the COVID-19 vaccine, but in a 2009 letter of interpretation of flu vaccines, the agency said employers could require the vaccine, with the exception of medical reasons. OSHA also published a fact sheet in 2014 that states that employers can mandate vaccines to reduce infection risk in the workplace. Both the EEOC and OSHA will issue new guidance after a vaccine has received approval by the FDA. 

What can employers do to prepare? 

The CDC and the Advisory Committee on Immunization Practices (ACIP) has updated several guidelines in response to the COVID-19 vaccine, which gives information about the upcoming vaccine, and who should receive it. Even though it may be months until the vaccine is available to the general public, employers must start preparing. Here is how employers can start based on guidance from a recent Mercer webinar: 

Plan

  • Create a committee to plan and develop a vaccination strategy for your company. 

  • Determine how you will support employees in getting the vaccine. 

Connect

  • Talk to your insurance carrier and learn about their plans and potential resources in supporting the COVID-19 vaccinations. 

  • Check with the local public health department, wellness vendors, and vaccination providers to see what resources are available to support your vaccination plan.

Support

  • Share information and set expectations with your employees

  • Encourage employees to receive the vaccine when it is available. It is not too early to start communicating. 

  • Continue to support virtual work and employee wellbeing through 2021.