Highlights:
- AstraZeneca to Supply 500,000 More COVID-19 Antibody Therapy to US
- The World Health Organization advises countries to keep using AstraZeneca vaccine
- Statement from AstraZeneca: Update on the safety of COVID-19 Vaccine AstraZeneca
Coronavirus Latest News: AstraZeneca to Supply 500,000 More COVID-19 Antibody Therapy to US
On Tuesday, AstraZeneca said that it will supply the United States government with an additional 500,000 doses of its experimental, long-acting antibody-based COVID-19 combination treatment that is designed to protect those who are not able to be vaccinated.
The $205 million agreement to supply the AstraZeneca treatment – known as AZD7442 – builds on a deal that the drug manufacturer struck last year with the Department of Health and Human Services and the Department of Defense (DoD).
Under this deal, the U.S. invested $486 million for the development and supply of 100,000 doses of AZD7442, with the option to obtain an additional one million doses in 2021. AstraZeneca has a separate agreement to supply the DoD with 100,000 doses, bringing potential U.S. supplies of the treatment to 700,000 doses in 2021, and the total value of current agreements with the U.S. government to $726 million.
Pascal Soriot, AstraZeneca Chief Executive, said the long-acting antibody combination AZD7442 has the potential to offer “almost immediate protection” to those who are not able to be vaccinated, to both prevent infection or treat the disease in patients already infected with the virus.
The antibody therapy, which has yet to be approved by U.S. regulators, is designed to treat the disease rather than prevent it like the vaccine, which several countries have stopped using while reports of blood clots in some people are investigated.
The treatment is a combination of two monoclonal antibodies, AstraZeneca said, adding that the new agreement is contingent on an emergency use approval by the U.S. Food and Drug Administration. “The U.S. government’s support is critical in helping accelerate the development of AZD7442, which we believe will be an important tool in the fight against COVID-19,” Soriot said.
The total value of the deal now totals $726 million for up to 700,000 doses. Currently, AZD7442 is being evaluated in late-stage trials. The company also says that it currently does not expect any changes to its 2021 forecasts due to the deal.
While AstraZeneca has undergone a rollercoaster ride with its COVID-19 vaccine, it has been working on developing new treatments and repurposing its present drugs to prevent and treat coronavirus infections.
Coronavirus Latest News: The World Health Organization Advises Countries to Keep Using AstraZeneca Vaccine
On Monday, the World Health Organization (WHO) said that countries should keep using AstraZeneca’s COVID-19 vaccine, despite many governments halted rollouts due to blood clot fears. WHO chief scientist Soumya Swaminathan told a press briefing, “We do not want people to panic and we would, for the time being, recommend that countries continue vaccinating with AstraZeneca.”
Swaminathan’s comments came as numerous European nations suspended use of the vaccine, citing cases of blood clots in people who have received the shot. The World Health Organization said that its vaccine safety experts were looking at the data and would meet on Tuesday, while Europe’s medicines watchdog will hold a special meeting on Thursday.
Tedros Adhanom Ghebreyesus, WHO Director General said on Monday’s briefing, “WHO’s advisory committee on vaccine safety has been reviewing the available data, is in close contact with the European Medicines Agency, and will meet tomorrow.”
Ghebreyesus stressed though that countries’ decisions to suspend vaccinations with the AstraZeneca vaccine – after blood clots were seen in people who had received doses from two vaccine batches produced in Europe – were “precautionary.” He said, “This does not necessarily mean that these events are linked to vaccination. It is routine practice to investigate them and it shows that the surveillance system works and that effective controls are in place.”
Further, Swaminathan highlighted that no causal link had been established between clotting and the vaccine, which was jointly developed with the University of Oxford. She pointed out that some blood clot incidents among the general population were to be expected. She said, “So far we do not find an association between these events and the vaccine because the rates at which these events have occurred in the vaccinated group are, in fact, less than what you would expect in the general population at the same time.”
Mariangela Simao, WHO’s Assistant Director General for access to medicines and health products, also agrees. Simao noted that millions of doses of the AstraZeneca vaccine had been administered in Europe, and yet there had been no increase in blood clot events. She said, “So far it doesn’t look like there are more cases than would be expected for the period in the general population.”
Furthermore, Simao said, “The risk-benefit of… vaccinating using AstraZeneca vaccines and other vaccines outweigh the risk of COVID infection.”
Aside from their COVID-19 vaccine, AstraZeneca to supply 500,000 more COVID-19 antibody therapy to US, as well.
Coronavirus Latest News: Update on the Safety of COVID-19 Vaccine AstraZeneca
Amid rising concerns of its COVID-19 vaccine and news of AstraZeneca to supply 500,000 more COVID-19 antibody therapy to US, the company has issued an official statement.
“Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.
A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.
So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.
Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.
Ann Taylor, Chief Medical Officer, said: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”
In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.
The safety of the public will always come first. The Company is keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people get vaccinated when invited to do so.
COVID-19 Vaccine AstraZeneca, formerly AZD1222.COVID-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the recent Emergency Use Listing granted by the World Health Organization accelerates the pathway to access in up to 142 countries through the COVAX Facility.
AstraZeneca.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.”
