AstraZeneca reported today that early-stage trials of a coronavirus vaccine showed a robust immune response.
The best response came when two injections were employed.
Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 also showed the drug was well tolerated.
AstraZeneca has administrative and logistics operations in Delaware that at the last report employed about 1,500 in Delaware.
AstraZeneca share prices rose last week in anticipation of positive news but dropped two percent in early trading this morning as Wall Street opened on a down note.
The COV001 trials used 1,077 healthy adult participants, aged 18-55 years.
The results published in The Lancet British medical journal confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 percent of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and was maintained two months after injection.
The early safety responses confirmed that transient local and systemic reactions were common in the AZD1222 group and were comparable to previous trials and other adenoviral vector vaccines. Side effects included temporary injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise, and muscle ache.
No serious adverse events were reported.
Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, said: “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. The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this. We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
Late-stage Phase II/III trials are currently underway in the United Kingdom, Brazil and South Africa and are due to start in the US. Trials will determine how well the vaccine will protect from the COVID-19 disease and measure safety and immune responses in different age ranges and at various doses.
AstraZeneca continues to affirm its commitment for broad and equitable access to the vaccine, should late-stage clinical trials prove successful. So far, commitments to supply more than two billion doses of the vaccine have been part of agreements with the UK, US, Europe’s Inclusive Vaccines Alliance, the Coalition for Epidemic Preparedness, Gavi the Vaccine Alliance and Serum Institute of India.
The announcement is not anticipated to impact the company’s financial guidance for 2020 as expenses to progress the vaccine are anticipated to be offset by funding by governments and international organizations.
AstraZeneca is Based in Cambridge, UK.
