Oxford–AstraZeneca COVID-19 vaccine - Wikipedia

Vaccine against COVID-19

Oxford–AstraZeneca COVID-19 vaccine

Box containing 100 COVID-19 Vaccine AstraZeneca doses

Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesCOVID-19 Vaccine AstraZeneca,[1][2][3] AstraZeneca COVID-19 Vaccine,[4] Covishield[5]
Other namesAZD1222,[6][7]
ChAdOx1 nCoV-19,[8]
ChAdOx1-S,[9]
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [9]
  • CA: Schedule D; Authorized by interim order [4][10]
  • UK: Conditional and temporary authorisation to supply [2][11]
  • EU: Conditional marketing authorisation [12][13][14]
  • KR, BR – Approved[15][16]
IND, INA,[17] BD, AG, SV, DOM, MEX, NE, SL, SRB[18]:

Emergency Authorization only

Identifiers
CAS Number
DrugBank
UNII

Vial of the Oxford–AstraZeneca vaccine manufactured by the

Serum Institute of India

(marketed as Covishield in India and in a few other countries)

[5]

The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222,[7] is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[19][20][21][22] One dosing regimen showed 90% efficacy 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.[6] Another dosing regimen showed 62% efficacy when given as two full doses separated by at least one month.[6]

The vaccine was developed by Oxford University's Jenner Institute and Oxford Vaccine Group with the collaboration of the Italian manufacturer Advent Srl located in Pomezia, which produced the first batch of the COVID-19 vaccine for clinical testing.[23] The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green.[24][23]

The vaccine has a good safety profile with around 10% of recipients during clinical trials reporting mild adverse effects including injection site pain, headache and nausea.[25] More rarely, anaphylaxis may occur (the UK Medicines and Healthcare products Regulatory Agency (MHRA) has 234 reports out of approximately 11.7 million vaccinations as of 7 March 2021[update]).[25]

On 30 December 2020, the vaccine was first approved for use[11][26] in the UK's vaccination programme,[27] and the first vaccination outside of a trial was administered on 4 January 2021.[28] The vaccine has since been approved by several medicine agencies worldwide, such as the European Medicines Agency (EMA),[12][14] and the Australian Therapeutic Goods Administration (TGA),[9] and has been approved for an Emergency Use Listing (EUL) by the World Health Organization.[29]

In March 2021, a number of countries paused use of the vaccine out of fears it may be implicated in cases of blood clotting observed in vaccine recipients.[30] The European Medicines Agency (EMA),[31][32] the UK MHRA[33] and AstraZeneca[34] have stated that overall blood clotting rates were not higher than would be expected naturally. On 18 March 2021, the EMA announced that out of the around 20 million people that had received the vaccine in the EU and UK overall blood clotting rates were normal, but that it had identified 15 very rare cases of unusual blood clots accompanied by low levels of blood platelets that might be linked to the vaccine.[32] The EMA updated the vaccine information to inform patients about the remote possibility of such syndromes but confirmed that the vaccine's benefits still outweigh the risks.[32] Italy has resumed vaccinations with other countries expected to follow.[35]

Vaccine platform [ edit ]

The Oxford–AstraZeneca COVID-19 vaccine is a replication-deficient simian adenovirus vector, containing the full‐length codon‐optimised coding sequence of SARS-CoV-2 spike protein along with a tissue plasminogen activator (tPA) leader sequence.[36][37]

The adenovirus is called replication-deficient because some of its essential genes were deleted and replaced by a gene coding for the spike. Following vaccination, the adenovirus vector enters the cells, releases its genes, those are transported to the cell nucleus, thereafter the cell's machinery does the transcription in mRNA and the translation in proteins.

The one of interest is the spike protein, an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[38] Producing it following vaccination will prompt the immune system to attack the coronavirus through antibodies and T-cells if it later infects the body.[6]

History [ edit ]

2020 development [ edit ]

In February 2020, the Jenner Institute agreed a collaboration with the Italian company Advent Srl for the production of the first batch of a vaccine candidate for clinical trials.[39]

In March 2020,[40][41] after the Gates Foundation urged the University of Oxford to find a large company partner to get its COVID-19 vaccine to market, the university backed off from its earlier pledge to donate the rights to any drugmaker.[42] The U.K. government encouraged the University of Oxford to work with AstraZeneca instead of Merck & Co., a US based company. People at Oxford were reportedly concerned the vaccine would not be distributed worldwide. Government ministers also had concerns that a vaccine manufactured in the U.S. would not be available in the U.K., according to anonymous sources in Wall Street Journal. Financial considerations at Oxford and spin-out companies may have played a part.[43][44]

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.[45]

Clinical trials [ edit ]

In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[46]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[47]

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.[48][49][50] 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.[51] AstraZeneca was criticised 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.[52] While the trial resumed in the UK, Brazil, South Africa, Japan[53] and India, it remained on pause in the US till 23 October 2020[54] while the Food and Drug Administration (FDA) investigated a patient illness that triggered the clinical hold, according to the United States Department of Health and Human Services (HHS) Secretary Alex Azar.[55]

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.[56][57][58] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[59]

Results of Phase III trial [ edit ]

On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine's ongoing Phase III trials.[6][60] There was some 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.[61][62][63] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[64]

The full publication of the interim results from four ongoing Phase III trials on 8 December 2020 clarified these reports.[65] 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 placebo. Serious adverse events were balanced across the active and control arms in the studies, i.e. the active vaccine did not have safety concerns. 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 the vaccine group and the other in the control group, were considered to be unrelated to vaccination.[65]

A subsequent analysis, published on 19 February, has shown an efficacy of 76% 22 days after the first dose and increase to 81.3% when the second dose is given 12 weeks or more after the first.[66]

2021 development [ edit ]

In February 2021, Oxford–AstraZeneca indicated developments to adapt the vaccine to target new variants of the coronavirus,[67] with expectation of a modified vaccine being available "in a few months" as a "booster jab".[68] A key area of concern is whether the E484K mutation could impact the immune response and, possibly, current vaccine effectiveness.[69] The E484K mutation is present in the South African (B.1.351) and Brazilian (B.1.1.28) variants, with a small number of cases of the mutation also detected in infections by the original SARS-CoV-2 virus and the UK/Kent (B.1.1.7) variant.[69]

Scottish Study [ edit ]

A study was carried out by universities across Scotland of the effectiveness of first dose of Pfizer–BioNTech and Oxford–AstraZeneca COVID-19 vaccines against hospital admissions in Scotland, based on a national prospective cohort study of 5.4   million people. Between 8 December 2020 to 15 February 2021, 1,137,775 patients were vaccinated in the study, 490,000 of which were with the Oxford–AstraZeneca vaccine. The first dose of the Oxford–AstraZeneca vaccine was associated with a vaccine effect of 94% for COVID-19 related hospitalisation at 28–34 days post-vaccination. Results for both vaccines combined showed a vaccine effect for prevention of COVID-19 related hospitalisation which was comparable when restricting the analysis to those aged ≥80 years (81%). The majority of the patients over the age of 65 were given the Oxford–AstraZeneca vaccine. As of 22 February 2021[update], the study had not been peer-reviewed.[70][71]

Approvals [ edit ]

On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[125] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[126]

On 4 January 2021, Brian Pinker, 82, became the first person to receive the Oxford–AstraZeneca COVID-19 vaccine outside of clinical trials.[28]

The European Medicines Agency (EMA) received an application for a conditional marketing authorisation (CMA) for the vaccine on 12 January 2021. A press release stated that a 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 Hungarian regulator unilaterally approved the vaccine instead of waiting for EMA approval.[127]

On 29 January 2021, the EMA recommended granting a conditional marketing authorisation for AZD1222 for people 18 years of age and older,[12][13] and the recommendation was accepted by the European Commission the same day.[14][128]

On 30 January 2021, the Vietnamese Ministry of Health approved the AstraZeneca vaccine for domestic inoculation, the first to be approved in Vietnam.[129]

The vaccine has also been approved by Argentina,[130] Bangladesh,[131] Brazil,[132] the Dominican Republic,[93] El Salvador,[133] India,[134][135] Malaysia,[136] Mexico,[137] Nepal,[138] Pakistan,[139] the Philippines,[140] Sri Lanka,[141] and Taiwan[142] regulatory authorities for emergency usage in their respective countries.

On 7 February 2021, the vaccine roll out in South Africa was suspended. Researchers from the University of the Witwatersrand said in a prior-to-peer analysis that the AstraZeneca vaccine provided minimal protection against mild or moderate disease infection among young people.[143][144] The BBC reported on 8 February 2021 that Katherine O'Brien, director of immunisation at the World Health Organization, indicated she felt it was "really plausible" the AstraZeneca vaccine could have a "meaningful impact" on the South African variant particularly in preventing serious illness and death.[145] The same report also indicated the Deputy Chief Medical Officer for England Jonathan Van-Tam said the (Witwatersrand) study did not change his opinion that the AstraZeneca vaccine was "rather likely" to have an effect on severe disease from the South African variant.[145]

On 10 February 2021, South Korea granted its first approval of a COVID-19 vaccine to AstraZeneca, allowing the two-shot regimen to be administered to all adults, including the elderly. The approval came with a warning, however, that consideration is needed when administering the vaccine to individuals over 65 years of age due to limited data from that demographic in clinical trials.[146][147]

On 10 February 2021, the World Health Organization (WHO) issued interim guidance and recommended the AstraZeneca vaccine for all adults, its Strategic Advisory Group of Experts also having considered use where variants were present and concluded there was no need not to recommend it.[148]

On 16 February 2021, the Australian Therapeutic Goods Administration (TGA) granted provisional approval for COVID-19 Vaccine AstraZeneca.[9][1]

On 26 February 2021, the vaccine was authorized with terms and conditions by Health Canada.[149]

Suspensions [ edit ]

On 3 March 2021, Austria suspended the use of a batch of the vaccine after two persons suffered blood clot related complications after vaccination that resulted in one death.[150] In total four blood clot cases have been identified for the same batch of 1 million doses.[150] Although no causal link with vaccination had yet been established,[151] several other countries, including Denmark,[152] Norway,[152] Iceland,[152] Bulgaria,[153] Ireland,[154] Italy,[151] Spain,[155] Germany,[156] France, Netherlands[157] and Slovenia[158] also halted the vaccine rollout while awaiting the European Medicines Agency to finish a safety review. Indonesia is also halting their vaccine rollout awaiting more safety reviews from World Health Organization.[159]

On 11 March 2021, the European Medicines Agency stated that there was no indication that vaccination had caused blood clots, which are not listed as side effects with the vaccine.[150][31] According to the EMA, the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.[31] As of 11 March 2021[update], 30 cases of thromboembolic events had been reported among the almost 5 million people vaccinated in the European Economic Area.[31] The Medicines and Healthcare products Regulatory Agency of the UK has also stated that after more than 11 million doses administered it had not been confirmed that the reports of blood clots were caused by the vaccine and that vaccinations would not be stopped.[33] On 12 March 2021 the World Health Organization stated that a causal relationship had not been shown and that vaccinations should continue.[160]

On 14 March 2021, AstraZeneca has confirmed that after over 17 million people have been vaccinated in the European Union and UK there has been no evidence of an increased risk of blood clots in any particular country.[34] The company reported that as of 8 March 2021[update], across the EU and UK, there have been 15 events of deep vein thrombosis and 22 events of pulmonary embolism reported among those given the vaccine, which is much lower than would be expected to occur naturally in a general population of that size.[34]

On 15 March 2021, the German Paul-Ehrlich Institute reported that out of 1.6 million vaccinations seven cases of cerebral vein thrombosis in conjunction with a deficiency of blood platelets had occurred.[161] According to the PEI, the number of cases of cerebral vein thrombosis after vaccination was statistically significantly higher than the number of cases that would occur in the general population during a similar time period.[161] These reports prompted the PEI to recommended a temporary suspension of vaccinations until the EMA has completed their review of the cases.[162]

On 17 March 2021, the World Health Organization issued a statement on AstraZeneca COVID-19 vaccine safety signals which said that it considered the benefits of this vaccine outweighed its risks and recommended that vaccinations continue.[163]

On 18 March 2021, the EMA announced that out of the around 20 million people that had received the vaccine general blood clotting rates were normal, but that it had identified 7 cases of disseminated intravascular coagulation, and 18 cases of cerebral venous sinus thrombosis.[32] A causal link with the vaccine had not been proven, but the EMA decided to conduct further analysis and to inform patients of the remote possibility of such rare syndromes.[32] The EMA confirmed that the vaccine's benefits still outweigh the risks.[32] As a result of this statement, Italy has announced it will resume vaccinations with other countries expected to follow.[35]

Safety profile [ edit ]

As of 7 March 2021[update], the MHRA said that over 11.7 million Oxford–AstraZeneca vaccinations had been given.[25] Around 10% of recipients in the clincal trials experience adverse effects, mostly mild in nature, including "injection site tenderness, injection-site pain, headache, fatigue, myalgia, malaise, pyrexia (fever), chills, arthralgia, and nausea".[25] 234 cases of anaphylaxis had been reported. Across all COVID-19 vaccines types, incidences of Bell's palsy in vaccine recipients were no higher than would be expected naturally. 534 (237 Pfizer/BioNTech, 289 Oxford University/AstraZeneca, 8 other) people, mostly the elderly or infirm, had died shortly after vaccination, but this figure was consistent with an expected coincidental death rate, with no suggestion of a causal link.[25]

Production and supply [ edit ]

The vaccine is stable at refrigerator temperatures and costs around US$3 to US$4 per dose.[164] On 17 December, a tweet by the Belgian Budget State Secretary revealed the European Union (EU) would pay €1.78 ( US$2.16 ) per dose.[165]

According to AstraZeneca's vice-president for operations and IT, Pam Cheng, the company would 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.[61]

In June 2020, further to making 100   million doses available to the UK's NHS for their vaccination programme,[166] 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.[167] Catalent will be responsible for the finishing and packaging process.[168] The majority of manufacturing work will be done in the UK.[citation needed ]

On 4 June 2020, the World Health Organization's (WHO) COVAX (COVID-19 Vaccines Global Access) facility made initial purchases of 300   million doses from the company for low- to middle-income countries.[169] Also, AstraZeneca and Serum Institute of India reached a licensing agreement to supply 1   billion doses of the Oxford University vaccine to middle- and low-income countries, including India.[170][171]

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 from Novavax at US$3 per dose.[172]

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 400   million doses to all European Union member states.[173][174][175] However, the European Commission took over negotiations on behalf of the whole EU, signing a deal at the end of August.[176][177][178]

In August 2020, AstraZeneca agreed to provide 300   million doses to the USA 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.[179] It also reached technology transfer agreement with Mexican and Argentinean governments and agreed to produce at least 400 million doses to be distributed throughout Latin America. The active ingredients would be produced in Argentina and sent to Mexico to be completed for distribution.[180]

In September 2020, AstraZeneca agreed to provide 20   million doses to Canada.[181][182]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3   million doses.[183][184]

On 5 November 2020, a tripartite agreement was signed between the government of Bangladesh, Serum Institute of India and Beximco Pharma of Bangladesh. Under the agreement Bangladesh ordered 30   million doses of Oxford–AstraZeneca vaccine from Serum through Beximco for $4 per shot.[185]

In November 2020, Thailand ordered 26   million doses of vaccine from AstraZeneca.[186] It would cover 13   million people,[187] approximately 20% of the population, with the first lot expected to be delivered at the end of May.[188][189][190] The public health minister indicated the price paid was $5 per dose;[191] AstraZeneca (Thailand) explained in January 2021 after a controversy that the price each country paid depended on production cost and differences in supply chain, including manufacturing capacity, labour and raw material costs.[192] In January 2021, the Thai cabinet approved further talks on ordering another 35   million doses[193] and the Thai FDA approved the vaccine for emergency use for 1   year.[194][195] Siam Bioscience, a company owned by Vajiralongkorn, will received technological transfer,[196] and has the capacity to manufacture up to 200   million doses a year for export to ASEAN.[197]

Also in November, the Philippines agreed to buy 2.6 million doses,[198] reportedly worth around ₱700 million (approximately $5.6/dose).[199]

In December 2020, South Korea signed a contract with AstraZeneca to secure 20   million doses of its vaccine, reportedly worth equivalently to those signed by Thailand and the Philippines,[200] with the first shipment expected as early as January 2021. As of January 2021[update], the vaccine remains under review by the South Korea Disease Control and Prevention Agency.[201][202] AstraZeneca signed a deal with South Korea's SK Bioscience to manufacture its vaccine products. The collaboration calls for the SK affiliate to manufacture AZD1222 for local and global markets.[203]

On 7 January 2021, the South African government announced that they had secured an initial 1   million doses from the Serum Institute of India, to be followed by another 500,000 doses in February.[204]

Myanmar signed a contract with Serum Institute of India to secure 30   million doses of its vaccine in December 2020. Myanmar will get doses for 15   million people from February 2021.[205]

On 22 January 2021, AstraZeneca announced that in the event the European Union approved the COVID-19 Vaccine AstraZeneca, initial supplies would be lower than expected due to production issues at Novasep in Belgium. Only 31   million of the previously predicted 80   million doses would be delivered to the European Union by March 2021.[206] In an interview with Italian newspaper La Repubblica, AstraZeneca's CEO Pascal Soriot said the delivery schedule for the doses in the European Union was two months behind schedule. He mentioned low yield from cell cultures in one large-scale European site.[207] Analysis published in The Guardian also identified an apparently low yield from bioreactors in the Belgium plant and noted the difficulties in setting up this form of process, with variable yields often occurring.[208] As a result, the European Union imposed export controls on vaccine doses; controversy erupted as to whether doses were being diverted to the UK, and whether or not deliveries to Northern Ireland would be disrupted.[209]

On 24 February 2021, a shipment of the vaccine to Accra, Ghana via COVAX made it the first country in Africa to receive vaccines via the initiative.[210]

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External links [ edit ]

https://en.wikipedia.org/wiki/Oxford%E2%80%93AstraZeneca_COVID-19_vaccine