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Oxford–AstraZeneca COVID-19 vaccine

Oxford–AstraZeneca COVID-19 vaccine
AstraZeneca COVID-19 Vaccine (cropped).jpg
Oxford/AstraZeneca COVID-19 vaccine seen in a refrigerator
Vaccine description
Target diseaseCOVID-19
TypeModified chimpanzee adenovirus vector
Clinical data
Other namesAZD1222,
ChAdOx1 nCoV-19,[1]
COVID-19 Vaccine AstraZeneca,[2][3]
Covishield[4]
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
  • UK: Conditional and temporary authorization to supply [2][5]
  • IND, AG, SV, DOM, MEX, BD, NE, BR: EUA only
Identifiers
CAS Number
DrugBank
UNII
Vial of the Oxford–AstraZeneca vaccine (marketed as Covishield in India and a few other countries)[4]

The Oxford–AstraZeneca COVID-19 vaccine (codenamed AZD1222) is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[6][7][8][9] One dosing regimen showed 90% efficiency when a half-dose was followed by a full-dose after at least one month, based on mixed trials with no participants over 55 years old.[10] Another dosing regimen showed 62% efficiency when given as two full doses separated by at least one month.[10]

The research is being done by the Oxford University's Jenner Institute and Oxford Vaccine Group with the collaboration of the Italian manufacturer Advent Srl located in Pomezia within the IRBM campus that has produced the first batch of the Coronavirus vaccine for clinical testing.[11] The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green.[12][11]

As of December 2020, the vaccine candidate is undergoing Phase III clinical research.[13]

On 30 December 2020 the vaccine was approved for use[14] in the UK's vaccination programme, and the first vaccination was administered on 4 January 2021.[15]

Vaccine platform

The AZD1222 vaccine is a replication-deficient simian adenovirus vector, containing the full‐length codon‐optimized coding sequence of SARS-CoV-2 spike protein along with a tissue plasminogen activator (tPA) leader sequence.[16]

The researchers used the SARS-CoV-2 genome that had been sequenced in Wuhan. The modified chimpanzee adenovirus cannot replicate, so does not cause further infection, and instead acts as a vector to transfer the SARS-CoV-2 spike protein.[17]

The spike S1 protein is an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[18] After vaccination, this spike protein is produced, promoting the immune system to attack the coronavirus if it later infects the body.[19]

History

In February 2020, the Jenner Institute agreed a collaboration with Italian company Advent Srl for the production of the first batch a vaccine candidate for clinical trials.[20]

In June 2020, the US National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020.[21]

In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[22]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[23]

On 8 September 2020, AstraZeneca announced a global halt to the vaccine trial while a possible adverse reaction in a participant in the United Kingdom was investigated.[24][25][26] On 13 September, AstraZeneca and the University of Oxford resumed clinical trials in the United Kingdom after regulators concluded it was safe to do so.[27] AstraZeneca was criticized for vaccine safety after concerns from experts noting the company's refusal to provide details about serious neurological illnesses in two participants who received the experimental vaccine in Britain.[28] While the trial resumed in the UK, Brazil, South Africa, Japan[29] and India, it remained on pause in the US till 23 October 2020[30] while the FDA investigated a patient illness that triggered the clinical hold, according to the HHS Secretary Alex Azar.[31]

On 15 October 2020, Dr João Pedro R. Feitosa, a 28-year-old doctor from Rio de Janeiro, Brazil, who received a placebo instead of the test vaccine in a clinical trial of AZD1222, died from COVID-19 complications.[32][33][34] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[35]

On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine's ongoing phase 3 trials.[10][36] There was a little criticism of the methods used in the report, which combined results of 62% and 90% from different groups of test subjects given different dosages to arrive at a 70% figure.[13][37][38] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[39]

The full publication of these interim results, from four ongoing, blinded, randomised, controlled trials, on 8 December 2020, clarified these reports.[40] In the group who received the first dose of active vaccine more than 21 days earlier, there were no hospitalisations or severe disease, unlike those receiving the control vaccine. Serious adverse events were balanced across the active and control arms in the studies, i.e. the active vaccine wasn't considered to cause additional serious adverse events. A case of transverse myelitis was reported 14 days after booster vaccination as being possibly related to vaccination, with an independent neurological committee considering the most likely diagnosis to be of an idiopathic, short segment, spinal cord demyelination. The other two cases of transverse myelitis, one in vaccine group and the other in control group, were considered to be unrelated to vaccination.[40]

On 11 December 2020, AstraZeneca announced they will explore with the Russian Gamaleya Research Institute whether their two adenovirus-based vaccines, AZD1222 and Gam-COVID-Vac, could be combined to give improved protection levels. Clinical trials were expected to start in Russia before the end of 2020.[41][42]

On 27 December 2020, the chief executive of AstraZeneca, Pascal Soriot said he believed researchers have found a "winning formula" in form of the Oxford–AstraZeneca COVID-19 vaccine, where two doses were used.[43]

On 4 January 2021, Brian Pinker, 82, became the first person to receive the Oxford–AstraZeneca COVID-19 vaccine outside of clinical trials.[15]

Approval

On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[44] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[45]

The European Medicines Agency received an application for a Conditional Marketing Authorisation (CMA) for the vaccine on 12 January 2021. A press release stated that an recommendation on this could be issued by the agency by 29 January, with the European Commission then making a decision on the CMA within days.[3]

The vaccine has also been approved by Argentina,[46] El Salvador,[47] India,[48][49] Mexico,[50] Bangladesh,[51] Dominican Republic,[52] Pakistan,[53] Nepal[54] and Brazil[55] regulatory authorities for emergency usage in their respective countries.

Production and supply

The vaccine is stable at refrigerator temperatures and costs around US$3 to US$4 per dose.[56] On 17 December a tweet by the Belgium Budget State Secretary revealed the European Union (EU) would pay €1.78 (US$2.16) per dose.[57]

According to AstraZeneca's vice-president for operations and IT, Pam Cheng, the company will have around 200million doses ready worldwide by the end of 2020 and capacity to produce 100million to 200million doses per month once production is ramped up.[13]

In June 2020, further to making 100million doses available to the UK's NHS, for their vaccination programme,[58] AstraZeneca and Emergent BioSolutions signed a US$87 million deal to manufacture doses of the vaccine specifically for the US market. The deal was part of the Trump administration's Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.[59] Catalent will be responsible for the finishing and packaging process.[60] The majority of manufacturing work will be done in the UK.

On 4 June 2020, the World Health Organization's (WHO) COVAX facility made initial purchases of 300million doses from the company for low- to middle-income countries.[61] Also, AstraZeneca and Serum Institute of India (SII) reached a licensing agreement to supply 1billion doses of the Oxford University vaccine to middle and low income countries, including India.[62][63] On 29 September 2020, a grant from the Bill and Melinda Gates Foundation allowed COVAX to secure an additional 100million COVID-19 vaccine doses either from AstraZeneca or Novavax at USD$3 per dose.[64]

On 13 June 2020, AstraZeneca signed a contract with the Inclusive Vaccines Alliance, a group formed by France, Germany, Italy, and the Netherlands, to supply up to 400million doses to all European Union member states.[65][66][67]

In August 2020, AstraZeneca agreed to provide 300million doses to the US for US$1.2 billion, implying a cost of US$4 per dose. An AstraZeneca spokesman said the funding also covers development and clinical testing.[68] It also reached technology transfer agreement with Mexican and Argentinean governments and to produce at least 400 million doses to be distributed throughout the Latin America. The active ingredients would be produced in Argentina and sent to Mexico to be completed for distribution.[69]

In September 2020, AstraZeneca agreed to provide 20million doses to Canada.[70][71]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3million doses.[72][73]

In November 2020, Thailand ordered 26million doses of vaccine from AstraZeneca.[74] It requires two doses of vaccine per person, so the quantity ordered would only cover 13million people.[75] Prayut cabinet later approved budget for ordering 35million additional doses in January 2021.[76] Siam Bioscience, a company owned by Vajiralongkorn, will received technological transfer for co-investment.[77]

In December 2020, South Korea signed a contract with AstraZeneca to secure 20million doses of its vaccine, with the first shipment expected as early as January 2021. As of January 2021, the vaccine remained under review by the South Korea Disease Control and Prevention Agency.[78][79]

On 7 January 2021, the South African government announced that they have secured an initial 1million doses from the Serum Institute of India, to be followed by another 500,000 doses in February.[80]

Myanmar signed a contract with Serum Institute of India to secure 30million doses of its vaccine in last December 2020. Myanmar will get doses for 15million people from February 2021.[81]

References

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