British regulators green light low-cost AstraZeneca Covid-19 vaccine

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The AstraZeneca-Oxford coronavirus vaccine has been approved for emergency supply in the United Kingdom with the first doses being released today and vaccinations beginning early in the New Year.

The vaccine is not as effective as previously released Pfizer and Moderna vaccines. Still,  trials have shown that it stops severe cases of Covid-19 that lead to hospitalizations. AstraZeneca CEO Pascal Soriot said data now shows that the vaccine is as effective as the two vaccines currently being used.

The vaccine is far less expensive than the Pfizer-BioNTech ($19.50 a dose)  and Moderna ($37 a dose) vaccines. A $3 to $4 a dose, the AstraZeneca vaccine can be stored in a refrigerator rather than a special freezer.

The AstraZeneca vaccine could be widely used around the world in battling the pandemic, due to its cost and less stringent refrigeration requirements.

The U.S. government has agreed to buy hundreds of millions of doses of the vaccine.

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AstraZeneca has headquarters, manufacturing, and logistics operations in northern Delaware at sites in north Wilmington and near Newark. Estimated employment is 1,500.

The UK Medicines and Healthcare products Regulatory Agency granted provided emergency supply authorization for Covid-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunization of individuals 18 years or older.

The authorization recommends two doses administered in a timeframe of between four and 12 weeks. 

AstraZeneca is working with Public Health England and National Health Service England to support the deployment and roll-out of the vaccine in the UK. The company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.

Pascal Soriot, CEO, said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer, and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government, and the tens of thousands of clinical trial participants.”

Professor Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon as possible.”

The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III program led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorization during the health crisis.

AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. 

The vaccine can be stored, transported and handled at normal refrigerated conditions (36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

As announced on 23 November 2020, the primary efficacy endpoint based on a pooled analysis showed that the vaccine was 70.4 percent effective at preventing Covid-19 from occurring more than 14 days after receiving two doses of the vaccine.

Studies continue on one quirky finding that showed a dose and a half of the vaccine was more effective than a full dose. The current authorization is for two full doses.

A secondary efficacy endpoint demonstrated no cases of severe infections or hospitalizations in the vaccine group, AstraZeneca reported.

The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK and Brazil and South Africa.

The Lancet publication confirmed that AZD1222 was well tolerated and that there were no serious safety events confirmed related to the vaccine.

The participants were from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

In addition to the program led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally.

 

 

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