Regulatory News - January

EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S.

 EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S., a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus. The company is currently conducting trials in people to assess safety and immunogenicity (how well the vaccine triggers a response against the virus), and effectiveness. EMA will evaluate data from these and other clinical trials as they become available.

EMA’s second public meeting about the new COVID-19 vaccines (08 Jan 2021).

 EMA planned a second public stakeholder meeting on the approval and roll-out of COVID 19 vaccines in the EU on 08 January 2021. The objectives of this event are to explain to citizens the basis for the approval and use of the new COVID-19 vaccines and how the safety of the vaccines will be assured; provide information on the role of the European Commission and the national public Health Authorities on the roll-out of the vaccines; and listen to the public and stakeholders on their needs, expectations and any concerns. A recording will be available after the meeting.

EMA communication: Information on the first COVID-19 vaccine.

Additional information on the first COVID-19 vaccine, Comirnaty, has now been published in the EMA website:

• CHMP assessment report, in English
• Translations in all EU languages of the medicine overview
• Translations in all EU languages of the product information
• Full body of the core Risk Management Plan (plus Annex 4), in English

The documents can be accessed by clicking here. Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU.

EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation.

EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO. “As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”

A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. The high efficacy was also maintained across genders, racial and ethnic groups.

COVID-19 Vaccine Moderna is given as two injections into the arm, 28 days apart. The most common side effects with COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination. The most common side effects are pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

This press release and more information on this vaccine have been published here. You can also check EMA’s dedicated webpage on COVID-19 for the latest updates.