COVID 19 Update #5
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation jcm9144@gmail.com
SPECIAL REPORT #21.7 (Updated)
AstraZeneca, yesterday night, disclosed an updated analysis of AZD1222, its COVID-19 vaccine trial results.
The latest analysis was based on 190 cases of symptomatic disease and found that its effectiveness to be 76%.
A preliminary analysis, published earlier this week, based on 141 such cases, found the vaccine to be 79% effective.
The new analysis found the vaccine to be 85% effective in subjects 65 years and older and 100% effective in preventing severe disease or hospitalisation. There were eight cases of severe COVID-19 observed in the primary analysis with all of those cases in the placebo group.
The new data have been presented to the Data and Safety Monitoring Board.
Mene Pangalos, Executive Vice-President, Biopharmaceuticals R&D said : « The primary analysis is consistent with our previously released interim report, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. We look forward to filing our regulatory submission for Emergency Use Authorisation in the U.S. and preparing for the rollout of millions of doses across America.”
Paris, March 25, 2021
SPECIAL REPORT #21.7
COVID 19 Update #5
Since February 16, we were not in a position to edit our usual news flow, but we are back now.
During the last month we identified three major events:
- The approval of the Johnson and Johnson COVID-19 vaccine.
- The strong evolution of the vaccination situation in the United States and in the United Kingdom.
- The ups and downs of AstraZeneca/Oxford COVID-19 vaccine fate.
On Friday February 26, the Vaccines and Related Biologicals Products Advisory Committee (VRBPAC) voted in favour of the Johnson & Johnson adenovirus-based COVID-19 vaccine, which was approved by the U.S. FDA on February 27. The J&J vaccine is the third approved COVID-19 vaccine in the United States and the only one given through a single shot. The media and social media discussions were mainly about the J&J vaccine 66% overall effectiveness when compared with the more than 95% effectiveness of the Pfizer/BioNTech and Moderna jabs. J&J CEO Alex Gorky pointed to the vaccine 85% effectiveness rate against serious illness and 100% effectiveness at preventing death.
The J&J vaccine was approved by the European Medicines Agency (EMA) on March 11.
The company said it expects to have 4 million doses ready to ship by March 1, plus a total of 20 million doses by the end of March and a 100 million doses by mid-year in the United States. No similar comment was made concerning Europe.
Supporters of European health ambition can be deeply disappointed when they compare themselves. On Tuesday, March 23, the United States had injected more than 128 million doses of vaccines to American citizens (45 million of whom have received both doses). The 27-nation large European Union had only injected 55 million doses. The United Kingdom has achieved 30 million first and second doses. France claims a number of 8.8 million on the very same day. The battle over vaccination is clearly over numbers now that supply and deliveries are accelerating.
AstraZeneca falling from “Charybdis to Scylla”.
On Monday March 22, AstraZeneca reported a 79% efficacy result from a new phase 3 trial performed with its COVID-19 vaccine, to receive a U.S. Emergency Use Approval. In an extremely rare and unprecedented situation, the Data and Safety Monitoring Board (DSMB), that polices the integrity of the data, wrote a letter to AstraZeneca and to U.S. government stating: “The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release. The point is clear to the board is that the [vaccine efficacy number] ….they chose to release was the most favourable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process”. In his own statement AstraZeneca said the disclosure on Monday was based on an interim analysis and it will “immediately engage” with the DSMB “to share our primary analysis with the most up-to-date efficacy data” and will “issue results of that analysis within 48 hours.”
What happens to AstraZeneca public relations?
The list of missteps is long. It started with confusing basic science, when the half-dose vaccine was claimed to be more effective than the full dose regimen. It continued when the U.S. FDA felt that the company had not informed it quickly enough when a subject in the U.K. trial got seriously sick and that the company was slow to provide follow-up information. Then came the power struggle with the EU Commission when AstraZeneca said it would miss by a wide margin its delivery promise of doses in 2021 and the harsh debate over the public release of the supply agreement. On March 11, several large European countries paused their use of the vaccine following reports of rare blood clots among some young subjects vaccinated with the AstraZeneca jab. The European Medicines Agency said it could not rule out that the cases were related to the vaccine. And now this “misleading data” press release.
We are now eagerly looking forward to hear about the latest report by the Anglo-Swedish company in the next hours.
Paris, March 24, 2021
This document has been prepared by btobioinnovation and is provided to you for information purposes only. The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change. btobioinnovation has no obligation to update its opinions or the information in this document.
Last News
- Note de réflexion de fin d’année
- EMA re-examines its opinion and approves Leqembi for the treatment of Alzheimer’s disease
- Le déclassement de la France
Events
News archives
- December 2024
- November 2024
- October 2024
- September 2024
- August 2024
- July 2024
- June 2024
- March 2024
- February 2024
- January 2024
- November 2023
- September 2023
- July 2023
- April 2023
- March 2023
- January 2023
- December 2022
- November 2022
- October 2022
- August 2022
- June 2022
- May 2022
- April 2022
- March 2022
- January 2022
- December 2021
- November 2021
- October 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- October 2018
- June 2018
- May 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- September 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- June 2014
- May 2014
- April 2014
- March 2014
- January 2014
- November 2013
- September 2013
- July 2013
- May 2013
- April 2013
- March 2013
- January 2013
- December 2012
- November 2012
- October 2012
- March 2012