MedImmune, LLC was a wholly owned subsidiary of AstraZeneca before February 14, 2019, when it was announced that the MedImmune name and branding would be discontinued in favor of AstraZeneca.[1][2]
It produced Synagis, a drug for the prevention of respiratory infections in infants, which accounted for US$ 1.06 billion of its US$ 1.2 billion in revenue for 2005, and FluMist, a nasal sprayinfluenza vaccine introduced in 2004. MedImmune acquired FluMist when it purchased Aviron in 2002 for US$ 1.5 billion. FluMist sales totaled US$ 104 million in 2008, US$ 54.8 million in 2007, and US$ 36.4 million in 2006.[5]
FluMist was approved for children two years of age and older in 2007, but initially was approved only for healthy people ages 5 to 49, a significant limitation because it eliminated a significant market—young children who find injections objectionable. Sales of FluMist fell short of analysts' expectations for the first two years the drug was sold. FluMist was initially sold in a frozen form, which was difficult for doctors to store.[6]
MedImmune conducted successful clinical trials for a new generation of FluMist needle-free vaccine, called CAIV-T, which was approved by the U.S. Food and Drug Administration (FDA) in 2007, and is now the form offered on the market.
History
Molecular Vaccines, Inc. was founded by Wayne T. Hockmeyer, David Mott, and Dr. James Young in 1988.[6] In 1989, Molecular Vaccines, Inc changed its name to MedImmune, Inc.
On April 23, 2007, it was announced MedImmune and AstraZeneca entered into a definitive agreement under which AstraZeneca intended to acquire MedImmune in an all-cash transaction at US$ 58 per share, or about US$ 15.2 billion.[6] On 19 June 2007 AstraZeneca completed the acquisition paying US$ 15.2 billion primarily for its drug development pipeline. Analysts have criticised the take-over, claiming that AstraZeneca paid too much.[7] AstraZeneca chose to merge MedImmune with Cambridge Antibody Technology, which it had acquired in 2006, creating a new biologics division under the MedImmune name. AstraZeneca presented the new MedImmune to investors on 7 December 2007.[8]
MedImmune said it was making a significant, rapid response with a vaccine to the novel H1N1 variant of influenza, known as swine flu.[10] In June 2009 it won a Department of Health and Human Services (HHS) contract, worth $90m. Under the contract with HHS, MedImmune will continue to make its seasonal FluMist vaccine and also develop a vaccine targeted specifically at the novel H1N1 virus.[5] MedImmune then won a second contract to test its nasal spray flu technology as a viable treatment for the H1N1.[11]
MedImmune received approval from the U.S. FDA for its intranasal novel H1N1 influenza vaccine in September 2009.[10]
Pipeline
MedImmune had over 120 drugs in development for conditions including lupus, COPD, asthma, and many types of cancer. Major phase III trials included:[12]
↑ MedImmune Press release MedImmune and National Institutes of Health Begin Clinical Testing of a Live, Attenuated Intranasal Vaccine Against an H5N1 Avian Influenza Virus published June 15, 2007
AstraZeneca plc is an Anglo-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. The United States Centers for Disease Control and Prevention (CDC) estimates that vaccination against influenza reduces sickness, medical visits, hospitalizations, and deaths. Immunized workers who do catch the flu return to work half a day sooner on average. Vaccine effectiveness in those over 65 years old remains uncertain due to a lack of high-quality research.
Live attenuated influenza vaccine (LAIV) is a type of influenza vaccine in the form of a nasal spray that is recommended for the prevention of influenza.
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. CSL's product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. The company was established in 1916 as Commonwealth Serum Laboratories and was wholly owned by the Australian federal government until its privatisation in 1994.
Swine influenza is an infection caused by any of several types of swine influenza viruses. Swine influenza virus (SIV) or swine-origin influenza virus (S-OIV) refers to any strain of the influenza family of viruses that is endemic in pigs. As of 2009, identified SIV strains include influenza C and the subtypes of influenza A known as H1N1, H1N2, H2N1, H3N1, H3N2, and H2N3.
In virology, influenza A virus subtype H1N1 (A/H1N1) is a subtype of influenza A virus. Major outbreaks of H1N1 strains in humans include the 1918 Spanish flu pandemic, the 1977 Russian flu pandemic and the 2009 swine flu pandemic. It is an orthomyxovirus that contains the glycoproteins hemagglutinin (H) and neuraminidase (N), antigens whose subtypes are used to classify the strains of the virus as H1N1, H1N2 etc. Hemagglutinin causes red blood cells to clump together and binds the virus to the infected cell. Neuraminidase is a type of glycoside hydrolase enzyme which helps to move the virus particles through the infected cell and assist in budding from the host cells.
An influenza pandemic is an epidemic of an influenza virus that spreads across a large region and infects a large proportion of the population. There have been six major influenza epidemics in the last 140 years, with the 1918 flu pandemic being the most severe; this is estimated to have been responsible for the deaths of 50–100 million people. The most recent, the 2009 swine flu pandemic, resulted in under 300,000 deaths and is considered relatively mild. These pandemics occur irregularly.
Influenza A virus subtype H3N2 (A/H3N2) is a subtype of viruses that causes influenza (flu). H3N2 viruses can infect birds and mammals. In birds, humans, and pigs, the virus has mutated into many strains. In years in which H3N2 is the predominant strain, there are more hospitalizations.
Transmission and infection of H5N1 from infected avian sources to humans has been a concern since the first documented case of human infection in 1997, due to the global spread of H5N1 that constitutes a pandemic threat.
Treatments for influenza include a range of medications and therapies that are used in response to disease influenza. Treatments may either directly target the influenza virus itself; or instead they may just offer relief to symptoms of the disease, while the body's own immune system works to recover from infection.
H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.
Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group.
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.
Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms begin from one to four days after exposure to the virus and last for about 2–8 days. Diarrhea and vomiting can occur, particularly in children. Influenza may progress to pneumonia, which can be caused by the virus or by a subsequent bacterial infection. Other complications of infection include acute respiratory distress syndrome, meningitis, encephalitis, and worsening of pre-existing health problems such as asthma and cardiovascular disease.
The pandemic H1N1/09 virus is a swine origin influenza A virus subtype H1N1 strain that was responsible for the 2009 swine flu pandemic. This strain is often called swine flu by the public media. For other names, see the Nomenclature section below.
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
A universal flu vaccine is a flu vaccine that is effective against all influenza strains regardless of the virus sub type, antigenic drift or antigenic shift. Hence it should not require modification from year to year. As of 2021 no universal flu vaccine had been approved for general use, several were in development, and one was in clinical trial.
A nasal vaccine is a vaccine administered through the nose that stimulates an immune response without an injection. It induces immunity through the inner surface of the nose, a surface that naturally comes in contact with many airborne microbes. Nasal vaccines are emerging as an alternative to injectable vaccines because they do not use needles and can be introduced through the mucosal route. Nasal vaccines can be delivered through nasal sprays to prevent respiratory infections, such as influenza.
Type A influenza vaccine is for the prevention of infection of influenza A virus and also the influenza-related complications. Different monovalent type A influenza vaccines have been developed for different subtypes of influenza A virus including H1N1 and H5N1. Both intramuscular injection or intranasal spray are available on market. Unlike the seasonal influenza vaccines which are used annually, they are usually used during the outbreak of certain strand of subtypes of influenza A. Common adverse effects includes injection site reaction and local tenderness. Incidences of headache and myalgia were also reported with H1N1 whereas cases of fever has also been demonstrated with H5N1 vaccines. It is stated that immunosuppressant therapies would reduce the therapeutic effects of vaccines and that people with egg allergy should go for the egg-free preparations.
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