mRNA pathophysiology

Clinical Trial of mRNA Universal Influenza Vaccine Candidate Begins

https://www.niaid.nih.gov/news....-events/clinical-tri

https://clinicaltrials.gov/ct2/show/NCT05755620

Clinical trial, experimental universal influenza vaccine

National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC),

(part of National Institutes of Health)

Enrolling volunteers, Duke University, Durham, North Carolina

Phase 1 trial

H1ssF-3928 mRNA-LNP, for safety and ability to induce an immune response.

N = up to 50 healthy volunteers, (18 through 49)

Three groups of 10 participants each

10, 25 and 50 micrograms

After evaluation of the data to determine an optimum dosage,

an additional 10 to receive the optimum dosage

Study include a group, receive a current quadrivalent.

Comparison between “immunogenicity and safety”

Follow-up appointments for up to one year

Annual seasonal flu vaccines

Valuable tools in controlling the spread and severity of influenza

Do not provide immunity against every flu strain.

Each year is based on prediction

Vaccine manufacturers then need time

(dominant strains of the virus can change)

An effective universal flu vaccine

Acting NIAID Director Hugh Auchincloss

Protecting its recipients against a wide variety of strains,

ideally providing durable long-term immunity.

“A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year”

Defence against the spread of a future flu pandemic.

Both vaccines use a specific portion of a flu protein,

Hemagglutinin (HA) stern (not head) flu protein



UK cements 10-year-partnership with Moderna in major boost for vaccines and research

https://www.gov.uk/government/....news/uk-cements-10-y

to produce up to 250 million vaccines per year

https://www.theguardian.com/bu....siness/2022/jun/22/m

£1bn deal with the UK government

UK government has committed to buying Moderna’s vaccines for the next decade.

Harwell, Oxfordshire

https://www.bbc.co.uk/news/uk-....england-oxfordshire-

Innovation and Technology Centre built by the 2025

Moderna

provide the UK public with access to mRNA vaccines for a wide range of respiratory diseases

Questions

Control of antigen dose?

How long antigen will be produced for?

Degree of systemic distribution?

Degree of systemic inflammation?