BREAKING - Covid-19 Pfizer BioNtech vaccine Comirnaty gets green light for use in Ireland and EU

Vaccine decision reached by the European Medicines Agency

Conor Ganly

Reporter:

Conor Ganly

Email:

news@leinsterexpress.ie

pfizer biontech coronavirus vccine covid-19

Nurse Joanna Sloane was the first person on the island of Ireland to be vaccinated when she got the jab at the Royal Victoria Hospital in Belfast

The European Medicines Agency (EMA) has given the green light for the Pfizer BioNtech vaccine meaning it will be available to be delivered to patients in Ireland within days.

The EMA has recommended granting conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission.

Officials at the EMA held an extraordinary meeting on Monday, December 21 as part of its evaluation of the COVID-19 vaccines. The meeting was held to assess additional information received from the company upon request of the Agency and to conclude the evaluation of the process which began after an application for use was made on December 1.

The EMA's Executive Director is Ms Emer Cooke from Ireland.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Ms Cooke, Executive Director of EMA.

“We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU,” she said.

The EMA said in a statement that a very large clinical trial showed that Comirnaty was effective at preventing COVID‑19 in people from 16 years of age.

It said the trial involved around 44,000 people in total. Half received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.

The agency said efficacy was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of the previous infection. It added that the study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95% efficacy in the clinical trial.

The trial also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2. The high efficacy was maintained across genders, racial and ethnic groups.

Comirnaty is given as two injections into the arm, at least 21 days apart. The EMA says the most common side effects were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the Member States, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

Following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) a marketing authorisation, the European Commission is due to fast track a decision to grant a marketing authorisation valid in all EU and EEA Member States within days.

The EMA says marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. It will be valid in all EU Member States at the same time enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time.

Under Ireland's plan, adults aged 65 and older who are in long term care will be the first to be vaccinated along with frontline workers and those essential to the vaccination programme. 

The role of EMA is the independent regulatory assessment of evidence generated for COVID-19 vaccines and to make recommendations on their authorisation and use in EU citizens.

The Agency says the scientific assessment recommending approval of vaccines is independent and driven by patient and public health needs. It adds that recommendation is be based on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and "nothing else".

The Pfizer BioNtech vaccine, which will be shipped to Ireland from Britain, is already in use in Britain and the United States.

The EMA is working on a number of other applications with a view to approving at least one, the Moderna vaccine in earlier 2021.