COVID-19 Update – The EU Commission Authorizes the Comirnaty Vaccine

The Latest

On Monday, the EU’s European Medicines Agency (“EMA”) recommended the authorization of the BioNTech/Pfizer Inc. vaccine.

An assessment report, with details of the EMA’s evaluation of Comirnaty, and the full risk management plan is due out in the coming days.

According to the EMA report, the recommendation was given for the following reasons:

• Comirnaty offers a high level of protection against COVID-19.
• The main trial showed that the vaccine has a 95% efficacy.
• Most side effects are mild to moderate in severity and are gone within a few days.

The EMA decided that the Comirnaty benefits outweighed the risks, allowing the recommendation for authorization.

Based on the recommendation, BioNTech/Pfizer Inc. will need to provide additional trial results. Clinical trials are to last for 2-years. One key unknown is the immunization period.

Following the EMA approval, the EU Commission approved the use of the vaccine for 16-year-olds and older.

The European Centre of Disease Prevention and Control welcomed the authorization.

The ECDC website stated that the vaccines will first reach those that are in most need of protection.

National authorities have defined and identified priority groups for vaccination. These include healthcare workers, the elderly, and the vulnerable.

What’s next?

Last week, both France and Germany had announced that vaccinations would begin before the end of the year. The news had come following the EMA’s decision to bring forward its review of the Comirnaty vaccine.

In the coming days, the markets will be looking for more details on the number of vaccine doses that will be made available to the EU. Also of interest will be how the EU Commission plans to allocate the vaccine doses.

Some EU member states are more adversely impacted by the COVID-19 vaccine than others.

Following news of the new strain of the coronavirus in the UK, there will be a greater sense of urgency to vaccinate high-risk groups sooner rather than later.

Before Monday’s authorization, the EU had pre-ordered 200 million BioNTech/Pfizer Inc. doses, with the option to purchase an additional 100 million doses in 2021.

AstraZeneca and Sputnik V

In addition, the EU also pre-ordered 400 million AstraZeneca doses.

A total of 700 million doses are sufficient to vaccinate 350 million EU citizens, That’s equivalent to 78% of the total population.

An additional 200 million doses would cover the shortfall, assuming that the EMA and EU Commission authorize the AstraZeneca vaccine.

The UK government expects independent regulator MHRA to authorize the AstraZeneca vaccine before the end of the year.

For the EU and beyond, the UK’s approval of the AstraZeneca vaccine will deliver a much-needed confidence boost.

Some of the most adversely affected countries, including India and Brazil, have only pre-ordered AstraZeneca doses.

With the number of new COVID-19 cases continuing to rise, pharmas are going to need to deliver more options. The more virulent strain identified in the UK has added more pressure on pharmas as new cases continue to spike.

Russia’s Sputnik V vaccine has become a viable alternative for some countries. This week, news hit the wires of India and Russia agreeing to jointly mass-produce the vaccine to deliver globally. Considering the spike in new COVID-19 cases across India and the delay to the AstraZeneca vaccine, the Sputnik V vaccine is critical. For poorer nations, both the Pfizer Inc. and Moderna Inc. vaccines are too expensive for mass vaccinations.

The Latest COVID-19 Numbers

At the time of writing, the total number of confirmed COVID-19 cases stood at 77,687,608. The total number of U.S cases has risen to 18,455,554, with the total number of related deaths rising to 326,679.

Behind the U.S, India saw the total number of cases break through the 10m level this week. Brazil has reported 7,264,221 cases in total.

For France, Germany, Italy, and Spain, the combined number of cases stood at 7,807,431, with 206,671 related deaths.

Across the United Kingdom, the total number of cases stood at 2,073,511, with 67,616 related deaths.