Bivalent new vaccine, Moderna press release
https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx
Omicron-containing bivalent COVID booster candidate, mRNA-1273.214
(original mRNA-1273 vaccine),
Superior neutralizing antibody response
in baseline seronegative participants.
increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels.
mRNA-1273.214 50 μg booster dose, well-tolerated in the 437 study participants
The safety and reactogenicity profile of the mRNA-1273.214 50 μg booster dose was similar to that of mRNA-1273 50 μg
BA.1
SARS-CoV-2 variants of concern and variants under investigation in England
Technical briefing 44
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1093275/covid-technical-briefing-44-22-july-2022.pdf
BA.2 3.4%
BA.4 17.2%
BA.5 78.7%
Other 0.7%
US variants
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
BA.5 88.8%
BA.4 5.3%
BA.4.6 5.1%
BA.2.12.1 0.8%
BA.2 0%
BA.1s 0%
Delta 0%
Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793551
Population-based cohort study of 297 individuals in Ontario, Canada,
with myocarditis or pericarditis following COVID-19 vaccination,
found higher rates of myocarditis or pericarditis associated with receipt of mRNA-1273 compared with BNT162b2 as a second dose,
particularly among male individuals aged 18 to 24 years.
The results suggest that there may be product-specific differences in rates of myocarditis or pericarditis after receiving mRNA vaccines
First bivalent COVID-19 booster vaccine approved by UK medicines regulator
https://www.gov.uk/government/news/first-bivalent-covid-19-booster-vaccine-approved-by-uk-medicines-regulator
Moderna bivalent approved for adult booster doses by MHRA
Spikevax bivalent Original/Omicron
25 micrograms targets the original virus strain
25 micrograms targets Omicron
Omicron (BA.1) and the original 2020 strain
(was also found to generate a good immune response against BA.4 and BA.5)
Safety monitoring
side effects observed were the same as those seen for the original Moderna booster dose,
and were typically mild and self-resolving,
and no serious safety concerns were identified.
Global covid deaths
https://www.worldometers.info/coronavirus/
6,466,947
Evidence cited by HMRA
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2822%2900320-6/fulltext
Based on official reported COVID-19 deaths,
we estimated that vaccinations prevented 14·4 million deaths from COVID-19 in 185 countries,
between Dec 8, 2020, and Dec 8, 2021.
19·8 million when we used excess deaths as an estimate
Joint Committee on Vaccination and Immunisation (JCVI) updated statement on the COVID-19 vaccination programme for autumn 2022
For autumn 2022
https://www.gov.uk/government/publications/jcvi-updated-statement-on-the-covid-19-vaccination-programme-for-autumn-2022/joint-committee-on-vaccination-and-immunisation-jcvi-updated-statement-on-the-covid-19-vaccination-programme-for-autumn-2022
JCVI advises
the following groups should be offered a COVID-19 booster vaccine:
residents in a care home for older adults and staff working in care homes for older adults
frontline health and social care workers
all adults aged 50 years and over
persons aged 5 to 49 years in a clinical risk group
persons aged 5 to 49 years who are household contacts of people with immunosuppression
persons aged 16 to 49 years who are carers
Time to collect PROSPECTIVE data
Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents
https://www.preprints.org/manuscript/202208.0151/v1
Thai adolescents, 13 to 18, both sexes
Cardiovascular effects
Found in 29.24% of patients,
Most common cardiovascular effects
Tachycardia, 7.64%
Shortness of breath, 6.64%
Palpitation, 4.32%
Chest pain, 4.32%
Hypertension, 3.99%
Abnormal ECG finding, 54 patients (17.94%)
Seven participants (2.33%)
(all male)
At least one elevated cardiac biomarker or positive lab assessments
https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx
Omicron-containing bivalent COVID booster candidate, mRNA-1273.214
(original mRNA-1273 vaccine),
Superior neutralizing antibody response
in baseline seronegative participants.
increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels.
mRNA-1273.214 50 μg booster dose, well-tolerated in the 437 study participants
The safety and reactogenicity profile of the mRNA-1273.214 50 μg booster dose was similar to that of mRNA-1273 50 μg
BA.1
SARS-CoV-2 variants of concern and variants under investigation in England
Technical briefing 44
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1093275/covid-technical-briefing-44-22-july-2022.pdf
BA.2 3.4%
BA.4 17.2%
BA.5 78.7%
Other 0.7%
US variants
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
BA.5 88.8%
BA.4 5.3%
BA.4.6 5.1%
BA.2.12.1 0.8%
BA.2 0%
BA.1s 0%
Delta 0%
Epidemiology of Myocarditis and Pericarditis Following mRNA Vaccination by Vaccine Product, Schedule, and Interdose Interval Among Adolescents and Adults in Ontario, Canada
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793551
Population-based cohort study of 297 individuals in Ontario, Canada,
with myocarditis or pericarditis following COVID-19 vaccination,
found higher rates of myocarditis or pericarditis associated with receipt of mRNA-1273 compared with BNT162b2 as a second dose,
particularly among male individuals aged 18 to 24 years.
The results suggest that there may be product-specific differences in rates of myocarditis or pericarditis after receiving mRNA vaccines
First bivalent COVID-19 booster vaccine approved by UK medicines regulator
https://www.gov.uk/government/news/first-bivalent-covid-19-booster-vaccine-approved-by-uk-medicines-regulator
Moderna bivalent approved for adult booster doses by MHRA
Spikevax bivalent Original/Omicron
25 micrograms targets the original virus strain
25 micrograms targets Omicron
Omicron (BA.1) and the original 2020 strain
(was also found to generate a good immune response against BA.4 and BA.5)
Safety monitoring
side effects observed were the same as those seen for the original Moderna booster dose,
and were typically mild and self-resolving,
and no serious safety concerns were identified.
Global covid deaths
https://www.worldometers.info/coronavirus/
6,466,947
Evidence cited by HMRA
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2822%2900320-6/fulltext
Based on official reported COVID-19 deaths,
we estimated that vaccinations prevented 14·4 million deaths from COVID-19 in 185 countries,
between Dec 8, 2020, and Dec 8, 2021.
19·8 million when we used excess deaths as an estimate
Joint Committee on Vaccination and Immunisation (JCVI) updated statement on the COVID-19 vaccination programme for autumn 2022
For autumn 2022
https://www.gov.uk/government/publications/jcvi-updated-statement-on-the-covid-19-vaccination-programme-for-autumn-2022/joint-committee-on-vaccination-and-immunisation-jcvi-updated-statement-on-the-covid-19-vaccination-programme-for-autumn-2022
JCVI advises
the following groups should be offered a COVID-19 booster vaccine:
residents in a care home for older adults and staff working in care homes for older adults
frontline health and social care workers
all adults aged 50 years and over
persons aged 5 to 49 years in a clinical risk group
persons aged 5 to 49 years who are household contacts of people with immunosuppression
persons aged 16 to 49 years who are carers
Time to collect PROSPECTIVE data
Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents
https://www.preprints.org/manuscript/202208.0151/v1
Thai adolescents, 13 to 18, both sexes
Cardiovascular effects
Found in 29.24% of patients,
Most common cardiovascular effects
Tachycardia, 7.64%
Shortness of breath, 6.64%
Palpitation, 4.32%
Chest pain, 4.32%
Hypertension, 3.99%
Abnormal ECG finding, 54 patients (17.94%)
Seven participants (2.33%)
(all male)
At least one elevated cardiac biomarker or positive lab assessments
