The European Medicines Agency (EMA) said on Tuesday (15 December) that its Human Medicines Committee (CHMP) has brought forward meeting for Pfizer-BioNTech COVID-19 vaccine to 21 December, more than a week ahead of its initial date 29 December, after mounting pressure from the public.
EMA said in a statement that the meeting planned for 29 December will be maintained, should it be needed.
“Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible,” it stated.
In the past weeks, the CHMP has been working with experts to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation application for BNT162b2 vaccine, said EMA.
“The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation,” it added.
EMA assured that the European Commmission will “fast track” their decision-making process to grant a marketing authorisation valid in all European Union and European Economic Area member states “within days” once the CHMP has given its approval.
“The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” it asserted.
The authorisation will carry all the safeguards, including a risk-management and safety monitoring plan, conditions for storage and other manufacturing controls, an investigation plan for use in children and a framework for evaluation of emerging efficacy and safety data, said EMA.
“A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines,” it noted.
The Pfizer-BioNTech vaccine has already received conditional approvals or emergency authorisations from four regulatory agencies, including the UK’s Medicines and Healthcare products Agency (MHRA), Health Canada, the US’ Food and Drug Administration (FDA), and Singapore’s Health Sciences Authority (HSA).
S’pore approves Pfizer-BioNTech’s COVID-19 vaccine
Over in Singapore, the HSA has recently granted an authorisation for the Pfizer-BioNTech COVID-19 vaccine to be used in the city-state, despite having lack of efficacy and safety data on some groups of people – pregnant women, people with compromised immune systems and those under the age of 16.
Prime Minister Lee Hsien Loong announced on Monday (14 December) that the agency has approved the COVID-19 vaccine, with the first shipment due to arrive in Singapore by the end of December.
In a statement, HSA claimed the data submitted by Pfizer and BioNTech on its vaccine was “robustly and thoroughly reviewed” by Singapore regulators, adding that international scientific standards were applied during the evaluation.
“HSA’s review of the available clinical data found that the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the known risks. The vaccine demonstrated a high vaccine efficacy of 95%,” it stated.
The vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR), which facilitates access to critical novel vaccines, medicines and medical devices during a pandemic, said HSA.
“Using PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a ‘rolling’, or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation,” it added.
Citing the vaccination regime submitted by Pfizer-BioNTech, HSA said two doses are required to be administered 21 days apart, in people aged 16 years and above.
“Pregnant women, immunocompromised persons and those under the age of 16 should also not receive the Pfizer-BioNTech vaccine as the safety and efficacy data on this group of persons is not available yet,” it said.
Additionally, people with a history of anaphylaxis or the rapid onset of severe allergic reactions should not receive the Pfizer-BioNTech vaccine as a precautionary measure.
Noting that the safety profile of the vaccine is “generally consistent” with other registered vaccines, HSA explained that some people may experience side effects such as pain, redness, swelling at the injection site, as well as fatigue, headache and muscle ache after vaccination.
While not everyone will experience these side effects, they are “common and expected” as part of the body’s natural response to build immunity against the COVID-19, it further noted.
“As a condition for the interim authorisation under PSAR, Pfizer and BioNTech are required to monitor the longer term efficacy of the vaccine to determine the duration of protection against COVID-19.
“This will augment the available data which shows that the vaccine continues to be effective for at least 2 months, with no signs of waning protection,” said HSA.
Pfizer and BioNTech are also required to continue to follow up on the safety of the vaccine for a longer period of time to determine its full safety profile.
“The companies must continue submitting the longer term follow up data to HSA to assure the continued effectiveness and safety of the vaccine. HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh the known risks,” said the agency.
Responding to a query about when the first vaccine shots would be given, the Ministry of Health (MOH) director of medical services Kenneth Mak said it would be more important to ensure that the vaccines are safely delivered and administered properly.
“We’re not fussed about whether or not there’s a period of time that passes between the vaccines arriving in Singapore and the first vaccinations starting, but we do want to make sure that we’re able to do this safely to our at-risk populations in Singapore in a timely fashion,” he told Yahoo News Singapore.
