On Nov. 25, 2020, the European Commission approved a contract with Moderna, a biotechnology company, under the EU Vaccines Strategy. The EU Vaccines Strategy was presented on June 17, 2020, in order to expedite the development and distribution of COVID-19 vaccines throughout Europe. The contract secured the initial purchase of 80 million doses of the Moderna COVID-19 vaccine, along with the option of buying up to another 80 million more vaccines once they are deemed safe for use.
On Jan. 6, 2021, the European Medicines Agency (EMA) recommended that the Commission grant the Moderna vaccine a conditional marketing authorization due to the urgent need for COVID-19 vaccines to be distributed quickly. This authorization category requires less comprehensive data than normally needed for approval and pushes the applicant to provide further information after its sanctioning instead of before. Similar to other methods of authorization, the data presented must suggest that the benefits of such medicine outweigh the consequences.
The EMA justified their recommendation by stating that the Moderna vaccine exhibited a 94.1% efficacy in a large clinical trial that involved thousands of people. They also noted the wide range of side effects, including nausea, fever, headaches, and more. However, they stated that these adverse effects tend to vanish after a few days. In addition, the EU pharmacovigilance system and European authorities will continue to provide additional studies regarding the vaccine even after it becomes available to the public.
Based on the EMA’s recommendation and endorsements from several member states, the Commission granted the Moderna vaccine a conditional marketing authorization on Jan. 6, 2021. This is the second vaccine they have authorized; the Commission approved the BioNTech-Pfizer vaccine on Dec. 21, 2020.
In January 2021, the Commission secured 160 million doses of the Moderna vaccine and started distributing them throughout Europe starting on Jan. 11, 2021. Those who take the vaccine must take one dose followed by a second dose 28 days later. The introduction of a second approved vaccine will speed up vaccination efforts in Europe, as the continent attempts to vaccinate 450 million people.
The Commission is also considering buying an extra 50 million doses of the Moderna vaccine, bringing the total number of Moderna doses to 210 million. This is in light of growing concerns that the number of vaccines administered in the EU is just under two doses per 100 residents, while the United States has provided over six per 100 residents. Additionally, the UK has surpassed both governments by administering over 10 doses per 100 residents.
Since the Moderna vaccine is mRNA-based, a fairly new and intricate process, Moderna must train more employees and adhere to strict guidelines, making it harder for the vaccine to be rapidly produced. Along with the vaccine’s lightning speed creation, Moderna must work to find or build large production sites in a short amount of time to continue to expand their orders.
Currently, Moderna relies on contractors due to their limited number of factories. For vaccines specifically sent to Europe, Moderna has partnered with the drug manufacturer Lonza Ltd. to produce active ingredients in Visp, Switzerland. Afterwards, fill-finish services for European vaccines are administered by ROVI, an industrial machine incorporation, and Recipharm, a pharmaceutical company.
Additionally, Moderna’s vaccine is expected to protect against other variants of the COVID-19 virus. In a press release on Jan. 25, Moderna voiced their confidence in their vaccine’s ability to protect against new strains, such as those first discovered in the U.K. and South Africa. These variants aren’t necessarily more dangerous, but they are considered more contagious, prompting the need for a sufficient vaccine. This will prove advantageous to the Commission as they attempt to minimize the spread of the new U.K. strain that was found in close proximity to other European nations. In fact, a study that Moderna released showed that the effectiveness of their vaccine was not significantly impacted when tested against the U.K. variant.
Against the current COVID-19 variant, the Moderna vaccine has been shown to be 94.5% effective after at least 14 days of a second dosage. Even after a single shot, the Moderna vaccine can provide up to 80.2% protection. Thus, it’s imperative that Moderna is able to safely distribute as many doses as possible to the EU as they continue their path of eradication.
Through Teen Lenses: “Would You Take the COVID-19 Vaccine if You Could Access it?”
“I would 100% take the COVID-19 vaccine because I am sick of staying at home and if I took the vaccine I could travel around and hang out with friends. I would also take it to protect high risk people who I could potentially spread the virus to.” Shayyan Ahmed, Sophomore, Richard Montgomery High School, Rockville, MD
“If the COVID-19 vaccine became available to me, I would rather not take it and pass it on to an essential/frontline worker or a senior. The COVID-19 vaccine is something that protects them from something they are most susceptible to. Instead of me wasting one, I would rather save someone else’s life as I just stay at home anyways.” Anniee Fang, Sophomore, Poolesville High School, Poolesville, MD
“Yes, definitely. People who don’t take the vaccine because they trust American cheese more than scientists are just stupid. They are putting other people at risk when scientists have given us a type of solution.” Joyce Zhou, Sophomore, Thomas S. Wootton High School, Rockville, MD