Bivalent new vaccine, Moderna press release

https://investors.modernatx.co....m/news/news-details/


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.serv....ice.gov.uk/governmen

BA.2 3.4%

BA.4 17.2%

BA.5 78.7%

Other 0.7%

US variants

https://covid.cdc.gov/covid-da....ta-tracker/#variant-

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/journa....ls/jamanetworkopen/f

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-

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/jour....nals/laninf/article/

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-up

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/manu....script/202208.0151/v

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