The National Pharmaceutical Regulatory Agency (NPRA) addresses some questions regarding Comirnaty, the Covid-19 vaccine made by Pfizer-BioNTech.
Q: What types of Covid-19 vaccines have been registered?
A: NPRA’s Drug Control Authority has granted Comirnaty conditional registration on Jan 8. Each dose of Comirnaty contains 30µg of nucleoside modified mRNA strand formulated as an RNA-lipid nanoparticle that encodes the viral spike (S) protein of the SARS-CoV-2, the virus responsible for Covid-19.
Q: What are the conditions for the vaccine’s registration?
A: Since the application was based on rolling submission of the latest data, the Product Registration Holder (PRH) will need to ensure all outstanding documents are submitted and deemed satisfactory by NPRA according to the timeline given. Apart from that, the PRH is required to monitor the safety profile of the vaccine and inform NPRA as soon as possible of any untoward incidents. The PRH is also required to conduct all activities planned under the Risk Management Plan and submit a monthly safety summary report to NPRA.
The validity of this conditional approval is one year. During this period, the Drug Control Authority will be periodically updated with the necessary information related to the quality, safety and efficacy of this vaccine. The registration can be revoked if the conditions are not fulfilled by the PRH or if the benefit-risk ratio no longer favours the vaccine.
Q: Why is Comirnaty granted conditional registration?
A: Clinical studies for Comirnaty are still ongoing. The current final analysis provided clearly shows a positive ratio of benefit over the risk. Further monitoring of the efficacy and safety is in place to ensure that the benefit-risk ratio remains positive.
Q: Who can be given Comirnaty?
A: Comirnaty is indicated for individuals 18 years of age and older. The use of this vaccine should be in accordance with the recommendations of the Health Ministry.
Q: Who should not get the Comirnaty vaccine?
A: Comirnaty should not be given to individuals who are known to have allergic reactions to any of the ingredients in the vaccine: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N, N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, potassium dihydrogen phosphate, sodium chloride, disodium phosphate dihydrate, and sucrose. The second dose of the vaccine should not be given to individuals who had a severe allergic reaction after the first dose.
Q: Can the following populations receive Comirnaty?
A: At the moment, there is insufficient clinical evidence to support vaccination for those who are immunocompromised and persons affected by autoimmune disorders. However, these recommendations may change as more clinical data is obtained. Please speak to your doctor to get the latest updates.
Q: If I have the following conditions, or am currently receiving or have received these treatments, can I receive the vaccine?
A: Please consult your doctor if you:
• Have any form of allergies, bleeding disorder or are taking any blood thinning medication;
• Recently or currently receiving treatment for cancer, organ or stem cell transplantation; and
• Had a previous history of Covid-19 infection, had previously received another Covid-19 vaccine (whether during an immunisation programme or was involved as a subject in a Covid-19 vaccine clinical study) or previously received passive antibody therapy for Covid-19.
You may receive the vaccine even if you have the above conditions. However, please speak with your doctor before deciding.
Q: How is the Comirnaty vaccine given?
A: Comirnaty should be injected into the deltoid muscle of the upper arm over two doses (0.3ml each), 21 days apart.
Q: How effective is Comirnaty in preventing Covid-19?
A: With current data from phase III clinical trials, the vaccine was 95% effective in preventing symptomatic Covid-19 disease, following completion of two doses of the vaccine.
Q: How long will Comirnaty provide protection?
A: As the clinical trial is still ongoing, no data is available to inform about the duration of protection that the vaccine will provide. However, this will be made known once updated data is available.
Q: Can individuals who had been infected by Covid-19 receive Comirnaty?
A: Based on clinical trial data, it is safe to give Comirnaty to those who had been infected by Covid-19. Since previously infected individuals can be at risk of Covid-19 (reinfection), vaccination may be offered to them.
Q: Can pregnant or breastfeeding women receive Comirnaty?
A: Clinical vaccine trials of the Comirnaty vaccine have excluded the pregnant and those who are nursing their child. Since there is no data on the safety and efficacy of this vaccine for these groups, recommendations cannot be made until further available data is obtained.
Q: Can children receive Comirnaty?
A: There is insufficient data on effectiveness and safety of this vaccine for those under 18 years old. Hence, children should not take the vaccine until such data is made available.
Q: What are the side effects of Comirnaty?
A: Comirnaty may cause:
• Very common side effects (may affect more than one in 10 people): injection site pain, injection site swelling, tiredness, headache, muscle pain, joint pain, chills and fever;
• Common side effects (may affect one in 100): injection site redness and nausea;
• Uncommon side effects (may affect one in 1,000): enlarged lymph nodes, feeling unwell, pain in limb, insomnia and injection site itching;
• Rare side effects (may affect one in 10,000): temporary one-sided facial drooping;
• Effects not yet known (cannot be estimated from available data): severe allergic reaction; and
• There is a remote chance that the vaccine could cause a severe allergic reaction even though the causal link has not been ascertained yet. A severe allergic reaction would usually occur within a few minutes to an hour after getting a dose of the vaccine. Signs of a severe allergic reaction can include difficulty in breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, or dizziness and weakness.
Recipients will be monitored for up to 30 minutes after the administration of this vaccine at the vaccination centre. During the marketing of Comirnaty in Malaysia, NPRA will monitor its use to ensure effectiveness and safety. Please inform your healthcare providers or report any side effects to the National Centre for Adverse Drug Reaction Monitoring at www.npra.gov.my [Consumers > Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)].
Q: What should I do after I am vaccinated?
A: Everyone should still continue to practise the Three Ws (Wash (hands), Wear (masks), Watch (your distance)) and avoid the Three Cs (Crowded space, Confined space, Close conversation), as well as observe all prevailing SOP.