Coronavirus (34) mRNA vaccine candidate for COVID-19: mRNA-1273 (part b)
The Moderna COVID-19 vaccine was approved by the UK government on 8th January, 2021. It is the third vaccine against COVID-19 approved to be used in the UK.1 Guidance from the UK government to health professionals in the use of mRNA-1273 gives us ideas of the details in the use of this vaccine, the safety issues and to whom the vaccine can be given.2
Administration of the COVID-19 Vaccine Moderna
According to the guidance, only people of age 18 years and older are allowed to receive the Moderna vaccine. The injection should be administered intramuscularly, ideally using the deltoid muscle of the upper arm. The vaccination is a two-dose programme, with the doses administered 1 month (28 days) apart.
The vaccine can be shipped and stored for up to 6 months at -20ºC, and then remain stable once thawed for 30 days if refrigerated at between 2ºC and 8ºC. Each vial of vaccine contains 10 doses. Once each vial is thawed and ready to be used, the health professional will withdraw only 0.5ml of vaccine from the vial for injection.
The vaccine is normally white to off-white in colour, and may contain white or translucent product-related particulates. At the time of injection, you can help to check the vaccine by visually inspecting if there is any other particulate matter and/or discolouration. The vaccine should not be used if either of these conditions exist.
Safety issues
From clinical trial studies, it was found that the administration of the vaccine could cause pain at the injection site, fatigue, headache, myalgia (muscle aches or pain), arthralgia (joint pain), chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema (skin redness) at the injection site. After the two doses of vaccination, the most common solicited adverse reactions included “injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%)”. Most of these reactions were mild to moderate. However, there was a higher occurrence of severe reactions after the second injection. Most of local reactions occurred within the first day or two after injection and then disappeared.
As events of anaphylaxis (severe, whole-body allergic reactions) have been reported, the guidance suggests health professionals should keep an eye on the patient for at least 15 minutes after vaccination. The guidance also suggests appropriate medical treatment and supervision to manage immediate allergic reactions be readily available in case of an acute anaphylactic reaction following administration of the COVID-19 Vaccine Moderna. Therefore, don’t panic if you suddenly experience an anaphylactic reaction immediately after injection: the vaccination centre should be ready to manage the situation. However, a second dose of the Moderna vaccine would not be given to you if you experienced severe allergic reactions after the first dose.
Precautions
According to the guidance, the following people will not be administered the Moderna COVID-19 Vaccine:
1. Children under 18 years of age;
2. People with severe allergic history;
3. Pregnant women. There is insufficient data to inform vaccine-associated risks in pregnancy. “Administration of COVID-19 Vaccine Moderna in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus”;
4. Women during breast-feeding. Data is not available to assess the effects of the Moderna vaccine on the breastfed infant or on milk production/excretion.
The guidance also suggests that health professionals should postpone the vaccination if individuals experience a severe febrile illness or severe acute infection. The jab can be provided to these individuals only when the acute illness has improved.
The guidance also says that “efficacy, safety and immunogenicity have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COVID-19 Vaccine Moderna may be less in these individuals.” If you are an immunocompromised person, who is also receiving immunosuppressive therapy, you should be bear in mind that you may have a diminished response to the Moderna vaccine, which means the protection you could get from the vaccination would be less than that of other people.
The efficacy of the Moderna vaccine is about 94%. Therefore, we have to understand that even if we have been vaccinated with one or two shots of the vaccine, the vaccination does not guarantee full protection. In any case, we should bear in mind that we have to wait at least 14 days after the second dose in order to get the maximum protection from the vaccination.
“The duration of protection afforded by the vaccine is unknown at present.” We may lose protection against the SARS-CoV-2 a certain period of time after the vaccination course. It is important to follow instructions from the government even after the whole nation’s vaccination scheme is completed.
References
1. Moderna becomes third Covid vaccine approved in the UK. By Michelle Roberts. BBC news. 8 January, 2021. https://www.bbc.co.uk/news/health-55586410
2. Regulatory approval of COVID-19 Vaccine Moderna. Regulation 174 Information for UK healthcare professionals. 8th January, 2021. https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
The Moderna COVID-19 vaccine was approved by the UK government on 8th January, 2021. It is the third vaccine against COVID-19 approved to be used in the UK.1 Guidance from the UK government to health professionals in the use of mRNA-1273 gives us ideas of the details in the use of this vaccine, the safety issues and to whom the vaccine can be given.2
Administration of the COVID-19 Vaccine Moderna
According to the guidance, only people of age 18 years and older are allowed to receive the Moderna vaccine. The injection should be administered intramuscularly, ideally using the deltoid muscle of the upper arm. The vaccination is a two-dose programme, with the doses administered 1 month (28 days) apart.
The vaccine can be shipped and stored for up to 6 months at -20ºC, and then remain stable once thawed for 30 days if refrigerated at between 2ºC and 8ºC. Each vial of vaccine contains 10 doses. Once each vial is thawed and ready to be used, the health professional will withdraw only 0.5ml of vaccine from the vial for injection.
The vaccine is normally white to off-white in colour, and may contain white or translucent product-related particulates. At the time of injection, you can help to check the vaccine by visually inspecting if there is any other particulate matter and/or discolouration. The vaccine should not be used if either of these conditions exist.
Safety issues
From clinical trial studies, it was found that the administration of the vaccine could cause pain at the injection site, fatigue, headache, myalgia (muscle aches or pain), arthralgia (joint pain), chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema (skin redness) at the injection site. After the two doses of vaccination, the most common solicited adverse reactions included “injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%)”. Most of these reactions were mild to moderate. However, there was a higher occurrence of severe reactions after the second injection. Most of local reactions occurred within the first day or two after injection and then disappeared.
As events of anaphylaxis (severe, whole-body allergic reactions) have been reported, the guidance suggests health professionals should keep an eye on the patient for at least 15 minutes after vaccination. The guidance also suggests appropriate medical treatment and supervision to manage immediate allergic reactions be readily available in case of an acute anaphylactic reaction following administration of the COVID-19 Vaccine Moderna. Therefore, don’t panic if you suddenly experience an anaphylactic reaction immediately after injection: the vaccination centre should be ready to manage the situation. However, a second dose of the Moderna vaccine would not be given to you if you experienced severe allergic reactions after the first dose.
Precautions
According to the guidance, the following people will not be administered the Moderna COVID-19 Vaccine:
1. Children under 18 years of age;
2. People with severe allergic history;
3. Pregnant women. There is insufficient data to inform vaccine-associated risks in pregnancy. “Administration of COVID-19 Vaccine Moderna in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus”;
4. Women during breast-feeding. Data is not available to assess the effects of the Moderna vaccine on the breastfed infant or on milk production/excretion.
The guidance also suggests that health professionals should postpone the vaccination if individuals experience a severe febrile illness or severe acute infection. The jab can be provided to these individuals only when the acute illness has improved.
The guidance also says that “efficacy, safety and immunogenicity have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COVID-19 Vaccine Moderna may be less in these individuals.” If you are an immunocompromised person, who is also receiving immunosuppressive therapy, you should be bear in mind that you may have a diminished response to the Moderna vaccine, which means the protection you could get from the vaccination would be less than that of other people.
The efficacy of the Moderna vaccine is about 94%. Therefore, we have to understand that even if we have been vaccinated with one or two shots of the vaccine, the vaccination does not guarantee full protection. In any case, we should bear in mind that we have to wait at least 14 days after the second dose in order to get the maximum protection from the vaccination.
“The duration of protection afforded by the vaccine is unknown at present.” We may lose protection against the SARS-CoV-2 a certain period of time after the vaccination course. It is important to follow instructions from the government even after the whole nation’s vaccination scheme is completed.
References
1. Moderna becomes third Covid vaccine approved in the UK. By Michelle Roberts. BBC news. 8 January, 2021. https://www.bbc.co.uk/news/health-55586410
2. Regulatory approval of COVID-19 Vaccine Moderna. Regulation 174 Information for UK healthcare professionals. 8th January, 2021. https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
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