Pandemrix

Key takeaways

Pandemrix belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Pandemrix to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Pandemrix from memory before moving on to harder problems.

Reference excerpt

Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006. The vaccine was one of the H1N1 vaccines approved for use by the European Commission in September 2009, upon the recommendations of the European Medicines Agency (EMEA). The vaccine is only approved for use when an H1N1 influenza pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU). The vaccine was initially developed as a pandemic mock-up vaccine using an H5N1 strain. Pandemrix was found to be associated with an increased risk of narcolepsy following investigations by Swedish and Finnish health authorities and had higher rates of adverse events than other vaccines for H1N1. This resulted in several legal cases. Stanford University studies suggested that narcolepsy is an autoimmune disease and that it appears to be triggered by upper airway respiratory infections. In 2018, a study team including Centers for Disease Control and Prevention (CDC) scientists analyzed and published vaccine safety data on adjuvanted pH1N1 vaccines (arenaprix-AS03, Focetria-MF59, and Pandemrix-AS03) from 10 global study sites. Researchers did not detect any associations between the vaccines and narcolepsy.

Constituents As well as the active antigen derived from A/California/7/2009 (H1N1), the vaccine contains an immunologic adjuvant AS03 which consists of DL-α-tocopherol (vitamin E), squalene and polysorbate 80. Thiomersal (thimerosal) is added as a preservative. Being manufactured in chicken eggs, it contains trace amounts of egg proteins. Additional important non-medicinal ingredients are formaldehyde, sodium deoxycholate, and sucrose.

Use of adjuvant While other 2009 H1N1 vaccines have been developed, the use of a proprietary immunologic adjuvant is claimed to boost the potency of the body's immune response, meaning that only a quarter of the inactivated virus is needed. Professor David Salisbury, Head of Immunisation at the UK Department of Health said the vaccines with adjuvants offer good protection even if the virus changes over time; "One of the advantages with adjuvanted vaccines is their ability to protect against drifted (mutated) strains. It opens the door for a whole new strategy in dealing with flu."

Dosage The vaccine is supplied in separate vials, one containing the adjuvant, and the other the inactivated virus, which require mixing before intramuscular injection. Originally it was thought that two doses given 21 days apart would be required for full efficacy. Subsequent testing has allowed the UK programme to consist of just a single dose for most people, with a two-dose schedule for children under the age of 10 years and immunocompromised adults.

Availability Pandemrix was given to around 70 million individuals, including 31 million Europeans following the 2009 swine flu pandemic. The Marketing Authorisation from the European Medicines Agency expired in August 2015 when GSK Biologicals did not apply for renewal of it citing lack of demand for the vaccine.

Clinical trials The EMEA reported results from some clinical trials in the CHMP Assessment Report. These relate to vaccination against H5N1 (Bird Flu) and not H1N1 (Swine Flu).

H5N1-007 was initiated at a single site in Belgium (Ghent) in March 2006. H5N1-008 was initiated at 41 sites in seven countries (6 EU MS plus Russia) in May 2006. H5N1-002 was initiated on 24 March 2007 in four SE Asian countries. GlaxoSmithKline reported results from the second clinical trial, from the pediatric clinical trial, and the response from the elderly population.

Side effects According to GlaxoSmithKline's Patient Information Leaflet, the following side effects may occur (sorted by rate of occurrence):

Very common Headache Tiredness Pain, redness, swelling or a hard lump at the injection site Fever Aching muscles, joint pain Common Warmth, itching or bruising at the injection site Increased sweating, shivering, flu-like symptoms Swollen glands in the neck, armpit or groin Uncommon Tingling or numbness of the hands or feet General constitutional upset of sleepiness or sleeplessness, generally feeling unwell, dizziness. Diarrhea, vomiting, stomach pain, feeling sick Skin reactions of itching, rash or urticaria (hives) Rare Serious generalised allergic reactions of anaphylaxis Fits Severe stabbing or throbbing pain along one or more nerves Low blood platelet count which can result in bleeding or bruising Very Rare Vasculitis Neurological disorders such as encephalomyelitis, neuritis or Guillain–Barré syndrome temporary paralysis

Adverse outcomes

… excerpt ends here. Continue reading the full article.

Illustrations

Worked examples

Example 1 — a first encounter with Pandemrix

Start with the simplest possible case. Write down what Pandemrix claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Pandemrix before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Pandemrix ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Pandemrix

In research: Pandemrix appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Pandemrix in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Pandemrix is common in secondary-school and first-year university syllabi. It links to neighbouring topics 2009 swine flu pandemic, Drugs developed by GSK plc, Inactivated vaccines, so understanding it makes those chapters shorter.
In everyday life: Look for Pandemrix outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

How to study Pandemrix in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Pandemrix means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Pandemrix out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Pandemrix in simple terms?

Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006.

Why does Pandemrix matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Pandemrix?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Pandemrix.