Oxford–AstraZeneca COVID-19 vaccine

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Oxford–AstraZeneca COVID-19 vaccine
Vaccine description
TargetCOVID-19
Vaccine typeModified chimpanzee adenovirus vector
Clinical data
Other namesOxford-AstraZeneca vaccine, ChAdOx1 nCoV-19,
Covishield (India)[1]
Routes of
administration		Intramuscular injection
ATC code
  • None
Legal status
Legal status
  • UK: Conditional and temporary authorization to supply[2][3]
  • IND, AG, SV, DOM, MEX, BD: EUA only
Identifiers
CAS Number
DrugBank
UNII
Part of a series on the
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AZD1222, also known as the Oxford-AstraZeneca vaccine, Covishield, or ChAdOx1 nCoV-19 is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[4][5][6][7] One dosing regimen showed 90% efficiency when a half-dose was followed by a full-dose after at least one month.[8] Another dosing regimen showed 62% efficiency when given as two full doses separated by at least one month.[8]

The research is being done by the Oxford University's Jenner Institute and Oxford Vaccine Group. The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green.[9][10]

As of December 2020, the vaccine candidate is undergoing Phase III clinical research.[11]

On 30 December 2020 the vaccine was approved for use[12] in the UK's vaccination programme, and the first vaccination was administered on 4 January 2021.[13]

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.[14]

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.[15]

The spike S1 protein is an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[16] After vaccination, this spike protein is produced, promoting the immune system to attack the coronavirus if it later infects the body.[17]

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.[18]

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.[19]

In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[20]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[21]

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.[22][23][24] 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.[25] 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.[26] While the trial resumed in the UK, Brazil, South Africa, Japan[27] and India, it remained on pause in the US till 23 October 2020[28] while the FDA investigated a patient illness that triggered the clinical hold, according to the HHS Secretary Alex Azar.[29]

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.[30][31][32] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[33]

On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine's ongoing phase 3 trials.[8] There was 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.[11][34][35] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[36]

The full publication of these interim results, from four ongoing, blinded, randomised, controlled trials, on 8 December 2020, clarified these reports.[37] 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 (TM) 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 TM cases, one in vaccine group and the other in control group, were considered to be unrelated to vaccination.[37]

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 are expected to start in Russia before the end of 2020.[38][39]

In 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. [40]

On 4 January 2021, Brian Pinker 82, became the first person to receive the Oxford-AstraZeneca Covid-19 vaccine outside of clinical trials.[13]

Approval

On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[41] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[42]

On 29 December, the Deputy Executive Director of the European Medicines Agency (EMA), Noel Wathion, stated that the EU regulator will most likely not be able to approve the vaccine until February. He said in an interview "They have not even filed an application with us yet".[43]

The vaccine has also been approved by Argentina,[44] El Salvador,[45] India,[46][47] Mexico,[48] Bangladesh[49] and the Dominican Republic[50] regulatory authorities for emergency usage in their respective countries.

Production and supply

The vaccine is stable at refrigerator temperatures and costs around $3 to $4 per dose.[51] On 17 December a tweet by the Belgium Budget State Secretary revealed the EU would pay €1.78 ($2.16) per dose.[52]

According to AstraZeneca's vice-president for operations and IT, Pam Cheng, the company will have around 200 million doses ready worldwide by the end of 2020 and capacity to produce 100 million to 200 million doses per month once production is ramped up.[11]

In June 2020, further to making 100 million doses available to the UK's NHS, for their vaccination programme,[53] 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.[54] Catalent will be responsible for the finishing and packaging process.[55] The majority of manufacturing work will be done in the UK.

On 4 June 2020, the WHO's COVAX facility made initial purchases of 300 million doses from the company for low- to middle-income countries.[56] Also, AstraZeneca and Serum Institute of India (SII) reached a licensing agreement to supply one billion doses of the Oxford University vaccine to middle and low income countries, including India.[57][58] On 29 September 2020, a grant from the Bill and Melinda Gates Foundation allowed COVAX to secure an additional 100 million COVID-19 vaccine doses either from AstraZeneca or Novavax at USD$3 per dose.[59]

On 13 June 2020, AstraZeneca signed a contract with Europe's Inclusive Vaccines Alliance, a group formed by France, Germany, Italy and the Netherlands, to supply up to 400 million doses to all European Union member states.[60][61][62]

In August 2020, AstraZeneca agreed to provide 300 million doses to the US for US$1.2 billion, implying a cost of US$4 a dose. An AstraZeneca spokesman said the funding also covers development and clinical testing.[63]

In September 2020, AstraZeneca agreed to provide 20 million doses to Canada.[64][65]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3 million doses.[66][67]

In November 2020, Thailand ordered 26 million doses of vaccine from AstraZeneca, which reported 70% overall efficacy.[68] It requires 2 doses of vaccine per person, so the quantity ordered would only covered 13 million people.[69] Prayut cabinet later approved budget for ordering 35 million additional doses in January 2021.[70] Siam Bioscience, a company owned by Vajiralongkorn, will received technological transfer for co-investment.[71]

In December 2020, South Korea signed a contract with AstraZeneca to secure 20 million doses of its vaccine, with the first shipment expected as early as January. As of January 2021, the vaccine remained under review by the South Korea Disease Control and Prevention Agency.[72][73]

On 7 January 2021 the South African government announced that they have secured an initial one million doses from the Serum Institute of India, to be followed by another 500,000 doses in February.[74]

References

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External links

Scholia has a profile for AZD1222 (Q95042269).
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