Vaccine Production Process Overview

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Questions and Answers

When does strain selection occur for vaccine preparation?

October to November

November to December

February to March (correct)

January to February

What is the primary purpose of the reassortant preparation phase in vaccine production?

To conduct clinical trials on vaccine safety

To create reassortant viruses for vaccine production (correct)

To produce the final vaccine for distribution

To blend different strains into a monovalent vaccine

What is typically conducted between April and September in the vaccine preparation timeline?

Clinical trials (correct)

Monovalent Bulk Production

Virus seed strain production

Fill and Finish

What occurs from November to January during the vaccine production process?

Virus seed strain production Signup and view all the answers

During which period is TRIs or quadivalent blending completed for the vaccine?

January to March Signup and view all the answers

What is the process that follows the blending and quality checks in vaccine production?

Fill and Finish Signup and view all the answers

What is the primary goal of the approval of clinical data phase?

To review the clinical trial data for safety and efficacy Signup and view all the answers

When does vaccine distribution begin in relation to the flu season?

August to November Signup and view all the answers

What age group represented the majority of averted deaths due to flu vaccination?

Adults age 65 years and older Signup and view all the answers

What is one reason for varying flu vaccine coverage from season to season?

Variations in antigenic match to circulating strains Signup and view all the answers

Which population group accounted for the majority of averted medical visits due to the flu vaccine?

Children aged 6 months to 17 years Signup and view all the answers

What is a significant factor in determining flu vaccine effectiveness?

Antigenic match to viral subtypes Signup and view all the answers

What percentage of symptomatic illness was averted for children from flu vaccination?

43% Signup and view all the answers

Which statement about overall flu vaccine coverage is accurate?

It varies slightly from season to season. Signup and view all the answers

What is the consequence of a poor antigenic match when administering the flu vaccine?

Decreased vaccine effectiveness Signup and view all the answers

Which group of adults had the highest percentage of averted hospitalizations from flu vaccination?

Adults aged 65 years and older Signup and view all the answers

What is the concept of original antigenic sin related to vaccine effectiveness?

It involves creating antibodies specific to the first virus encountered. Signup and view all the answers

Why might vaccine effectiveness vary among different age groups?

The immune response can differ due to variations in health status. Signup and view all the answers

What potential impact could the H3N2 strain have on vaccine effectiveness?

It may require updating the vaccine formulation regularly. Signup and view all the answers

How might original antigenic sin affect the immune response to future virus variants?

It undermines the production of antibodies specific to novel strains. Signup and view all the answers

What range was estimated for vaccine effectiveness in the 2023-24 season?

33% to 49% Signup and view all the answers

What phenomenon describes the immune response returning to the original strain of a virus upon subsequent exposure?

Original Antigenic Sin Signup and view all the answers

Which protein on the RSV surface is primarily responsible for attaching the virus to host cells?

G protein Signup and view all the answers

Which of the following groups is at the highest risk for severe lower respiratory tract infections (LRTI) caused by RSV?

Infants Signup and view all the answers

What is the primary vaccination target for RSV?

F protein Signup and view all the answers

What is the primary purpose of seasonal flu vaccines?

To protect against seasonal strains of influenza that may emerge Signup and view all the answers

When does the production process for the seasonal flu vaccine typically begin?

Around April to June Signup and view all the answers

During which months does RSV typically circulate in North America?

November - March Signup and view all the answers

What is the primary structural characteristic of RSV concerning its genetic material?

Single-stranded RNA virus Signup and view all the answers

How many strains of influenza does the seasonal flu vaccine generally target?

Two strains of type A and one strain of type B Signup and view all the answers

Which condition is NOT associated with severe RSV bronchiolitis in children?

Asthma exacerbation Signup and view all the answers

What is the development process for a seasonal flu vaccine described to potentially take?

Up to eight months Signup and view all the answers

How does RSV differ from influenza in terms of antigenic variability?

RSV can accumulate antigenic drift Signup and view all the answers

What type of vaccines are mentioned for the 2024-2025 flu season?

Cell- or recombinant-based and egg-based vaccines Signup and view all the answers

Which of the following strains is included in the egg-based vaccines for the 2024-2025 season?

A/Victoria/4897/2022 (H1N1)pdm09-like virus Signup and view all the answers

Which time frame encompasses the Southern Hemisphere influenza season?

April to September Signup and view all the answers

What differentiates the Northern Hemisphere vaccine timeline from that of the Southern Hemisphere?

Each step of the development is adapted to the flu season in each region Signup and view all the answers

Study Notes

Vaccine Production Timeline

Strain Selection occurs from February to March, informed by surveillance data.
Reassortant Preparation is conducted from October to April to create reassortant viruses for vaccine production.
SRID Reagent Preparation takes place from November to December and again from April to May, ensuring antigen potency.
Virus Seed Strain Production occurs between November to January and April to June to produce required strains for bulk production.
Monovalent Bulk Production happens from December to February and May to July, creating bulk amounts of each selected strain.
TRI or Quadrivalent Blending occurs from January to March and June to August, combining different virus strains into the final vaccine formulation.
Fill and Finish is the packaging phase from August to October and February to April after blending and quality checks.
Vaccine Release occurs after quality control checks from August to October and March to May, allowing public access.
Submission of CMC Data happens from August to October and February to April for final regulatory approval.
Clinical Trials are conducted from April to September and December to March to establish safety and efficacy.
Approval of Clinical Data occurs from July to September and March to April, reviewing trial results before release.
Vaccine Distribution begins around August to November and April to June to ensure availability preceding flu seasons.

Influenza Vaccine Composition and Effectiveness

Seasonal flu vaccines are updated annually to protect against three strains: two A strains and one B strain.
Estimated development duration for a seasonal flu vaccine is up to eight months from strain selection to final product.
For the 2024-2025 season, egg-based vaccines will target specific H1N1, H3N2, and B strains, while cell- or recombinant-based vaccines will target similar but updated strains.
Vaccine effectiveness varies based on antigenic match with circulating strains and populations (age, underlying health conditions).
Vaccine coverage rates fluctuate between seasons, typically not reaching optimal levels (80% target).
Vaccination significantly reduces hospitalizations and deaths, particularly among adults over 65 and children.

Immunological Considerations

Original Antigenic Sin describes how prior exposure to a virus influences the immune response to new variants, potentially leading to reduced effectiveness against newer strains.
Respiratory Syncytial Virus (RSV):
- Identified in the 1950s; first in infants with severe lower respiratory tract infections (LRTI).
- RSV circulates predominantly from November to March in North America.
- Surface proteins, G and F, are vital for host cell attachment and invasion.
- Common symptoms include acute respiratory issues, particularly in infants and older adults or immunocompromised individuals.

Clinical Implications

RSV can result in significant hospitalizations, especially in infants and older adults with underlying conditions.
Strategies for immunization and treatment must account for the diverse nature of circulating strains and individual health factors.

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Description

This quiz covers the crucial timelines and procedures involved in vaccine production, focusing on strain selection, reassortant preparation, and reagent preparation. It highlights the specific months dedicated to each phase, ensuring a comprehensive understanding of the vaccine development process.