Leader of the Pack?

AstraZeneca has potentially taken the lead in the current COVID-19 vaccine development race, through robust Phase I/II trial results and numerous deals being struck for supply, as well as media hype over a possible ‘fast track’ status in the United States, albeit denied by the company. So, will AstraZeneca’s hope of being able to deliver AZD1222 before the end of 2020 actually come true?

Positive outcomes so far

The AZD1222 vaccine is currently in late-stage Phase II/III trials in the United Kingdom, Brazil, and South Africa. Interim results from the Phase I/II trial, led by Oxford University, were released in July 2020 and demonstrated a robust antibody and T-cell response in all participants (1).

“The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type,” said Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, in a press release (1). Further results on the immunogenicity and efficacy of the vaccine are expected to be available between September and November 2020.

Supply to meet potential demand

Since forming the partnership with the University of Oxford for the global development and distribution of the COVID-19 vaccine (2), AstraZeneca has established numerous agreements for the supply of the AZD1222 vaccine globally. For example, AstraZeneca and the European Commission recently concluded an agreement for the supply of up to 400 million doses (3), which adds to a prior arrangement the company had formed with the Inclusive Vaccines Alliance (4).

Additionally, supply and manufacturing agreements for AZD1222 have been set up with several partner companies, including Catalent and Cobra Biologics (5,6). AstraZeneca has been working on manufacturing the vaccine at scale to ensure broad and equitable access in the case of successful late-stage clinical trials and regulatory approval.

On a fast track … not yet!

US President, Donald Trump, is also reportedly pushing to get AZD1222 fast tracked through approval, so that it will be available to the US population before November’s elections. However, according to a report by The Independent, who spoke with AstraZeneca on the matter, the company has not been in discussions over emergency use authorization within the US (7).

“It would be premature to speculate on that possibility,” the AstraZeneca spokesperson told The Independent (7). “Late-stage Phase II/III trials for AZD1222 are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year.”

A cautious approach

Irrespective of the rapid pace at which companies, such as AstraZeneca, have been developing prospective vaccines and treatments to tackle the current COVID-19 crisis, clinical data and ultimately a thorough regulatory review are required. So, in terms of AZD1222, there may well be sufficient data by the end of the year to suggest efficacy and safety, but the regulatory bodies will still need to issue approvals before it can be used.

As reported in The Guardian, Professor Chris Whitty—England’s chief medical officer—has suggested that a vaccine may not be ready until winter in 2021 (8). Oftentimes, it is better to hope for the best, but prepare for the worst, and for vaccine development, sufficient data and regulatory review are critical requirements.

For now, stay alert, safe, and healthy.

References

1. AstraZeneca, “COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial,” Press Release, 20 July 2020.
2. AstraZeneca, “AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine,” Press Release, 30 April 2020.
3. EC, “Coronavirus: Commission Reaches First Agreement on a Potential Vaccine,” Press Release, 14 Aug. 2020.
4. AstraZeneca, “AstraZeneca to Supply Europe with up to 400 Million Doses of Oxford University’s Vaccine at No Profit,” Press Release, 13 June 2020.
5. Catalent, “Catalent Signs Agreement with AstraZeneca to Expand Manufacturing Support for COVID-19 Vaccine AZD1222,” Press Release, 24 Aug. 2020.
6. Cobra Biologics, “Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate,” Press Release, 16 June 2020.
7. Matt Mathers, “Trump ‘Considering Fast-Tracking UK’s Coronavirus Vaccine Before US Election’,” News Story, The Independent, 24 Aug. 2020.
8. PA Media, “Whitty Says it Would be Foolish to Count on Having COVID Jab by Winter,” News Story, The Guardian, 22 Aug. 2020.

Article Details

Pharmaceutical Technology Europe
Vol. 32, No. 9
September 2020
Page: 5

Citation

When referring to this article, please cite it as F. Thomas, “Leader of the Pack?” Pharmaceutical Technology Europe 32 (9) 2020.