Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
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
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