Latest news with #Bourla
Yahoo
4 days ago
- Business
- Yahoo
Pfizer CEO: HHS claims of ‘concealed safety concerns' on mRNA vaccines are ‘completely inaccurate'
Pharmaceutical rivals don't often come to each other's defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that 'mRNA technology remains under-tested,' Pfizer's chief executive is speaking up. 'MRNA probably is the most utilized vaccine in the history of humanity,' Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. 'So it is extremely well-tested.' HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. 'We concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable,' an HHS spokesperson said, claiming, 'the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.' Asked his response to those comments, Bourla responded, 'both of them are completely inaccurate.' The pharma giant's chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world's largest meeting on cancer research. Pfizer's drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It's a 'very, very important finding,' Bourla said, noting that colorectal cancer rates, 'particularly among younger people, are skyrocketing right now.' And while Pfizer is making big bets on cancer research, its CEO said he's not taking his foot off the pedal with investment in vaccines either, despite a 'very big gap' between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. 'The science is proven,' Bourla said. 'The things they will do that will reduce, maybe, vaccination rates will come back and bite us.' Diseases will return, he said, and 'that will not take a long time.' Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably 'means that immediately they will have to reverse it,' Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and 'they will go back to what every country in the world is doing.' Bourla worked with the first Trump administration to advance the company's Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn't accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, 'when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.' Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the 'pill penalty' – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers' role in drug pricing. 'We are working to address those things as we agree to disagree on the things that divide us,' Bourla said. He noted that he is against the administration's proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is 'the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,' in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. 'If we break any link of this chain of this large ecosystem,' Bourla said, 'that's not good for us, and actually, it's a gift to our friends in China.' Bourla also took issue with HHS's actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren't in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine's effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What's more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, 'You are raising some very real concerns that we have.' Bourla noted that the implications of the Trump administration's changes to US health agency policies aren't entirely clear. But 'the issue is that that is not based on any scientific data. It's just based on a belief.' 'The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let's say, a new rule,' he said. 'You need to follow a process which is reviews, experts, professional staff of FDA and all of that.' Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS's 'bad administrative procedure' in announcing the updated CDC recommendations 'will be an issue' if they're challenged in court. Would Pfizer consider filing a lawsuit? 'My initial reaction is that I would prefer to find solutions but not create tensions,' Bourla replied. 'But of course, if we feel that we have to, we will.' Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that 'we maintain a very, very close relationship' with the White House. 'I can't complain they don't listen to us,' Bourla said.
Yahoo
14-05-2025
- Business
- Yahoo
Ursula von der Leyen was wrong to conceal vaccine texts to Pfizer boss, court rules
The European Commission was wrong to conceal messages between Ursula von der Leyen and the boss of Pfizer during negotiations over coronavirus vaccines, an EU court has found. The EU body had refused to hand over the private correspondence between its president and Albert Bourla ahead of a multibillion-euro deal to procure jabs from the firm. Judges at the European Court of Justice's General Court backed a legal challenge against the decision to withhold the contents of the messages. Announcing its decision, the Luxembourg-based court said the Commission had 'not given a plausible explanation to justify the non-possession of the requested documents'. 'Moreover, the commission has not sufficiently clarified whether the requested text messages were deleted and, if so, whether the deletion was done deliberately or automatically or whether the president's mobile phone had been replaced in the meantime,' it added. Journalists from The New York Times had asked the court to force the release of the conversations between Commission president Mrs von der Leyen and Pfizer's Mr Bourla from 2021. Details of their exchanges could open up details of how costly their deal to procure millions of vaccines at breakneck speed was for European taxpayers. The scandal, dubbed 'Deletegate', had already opened up scrutiny over how the EU's most senior officials are allowed to conduct business in private. The private exchange between Mrs von der Leyen and Mr Bourla came at a time when the EU was scrambling for much-needed doses of coronavirus vaccines, with AstraZeneca struggling to fulfil its promised orders. The EU chief eventually agreed to buy as many as 1.8 billion shots between 2021 and 2023 doses from Pfizer, in a deal The New York Times reported at the time had been negotiated by text. Wednesday's ruling will serve as an embarrassing reminder for Mrs von der Leyen, who has always billed herself as an honest broker and business-like professional to lead the Commission. While the ruling can be appealed, it is likely going to open a fresh can of worms over how text messages are treated in freedom of information cases in the future. The Commission had never argued that the text messages had not existed, but argued that they were not deemed important for records to be properly kept. The EU's executive branch had previously claimed that the messages had been deleted because of their 'short-lived, ephemeral nature'. Transparency and anti-corruption campaigners said the ruling should prompt a significant reform to the Commission's freedom of information policies. 'Today's decision is a victory for transparency and accountability in the European Union, and it sends a powerful message that ephemeral communications are not beyond the reach of public scrutiny,' Nicole Taylor, of The New York Times, said. In response to the ruling, the Commission said it would study the ruling and decide 'on next steps', which could include an appeal at the ECJ. 'Transparency has always been of paramount importance for the Commission and President von der Leyen,' it said. Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Yahoo
14-05-2025
- Business
- Yahoo
EU Commission loses on all counts in Pfizergate legal case
After a long tug-of-war between the European Commission and The New York Times over transparency surrounding the Pfizer COVID-19 vaccine contracts, the European Court of Justice (ECJ) today ruled that the Commission 'has not given a plausible explanation to justify the non-possession of the requested documents.' According to the Court, the Commission cannot simply claim it does not hold the requested documents; it must provide credible explanations that enable both the public and the Court to understand why those documents cannot be located. The ECJ found that The New York Times had submitted relevant and consistent evidence indicating the existence of text messages between the President of the Commission and the CEO of Pfizer regarding the procurement of COVID-19 vaccines. 'These contracts were totally unprecedented in a totally unprecedented context,' said an EU official ahead of the ruling. The Pfizer-BioNTech vaccine was the first to receive EU authorisation in December 2020, after an advance purchase agreement for 200 million doses. Subsequent contracts in March and May 2021 secured an additional €2.4 billion worth of doses, with an option for 900 million more. The publication uncovered the existence of the messages in 2021 during interviews with Bourla, but encountered obstacles when requesting access to them. The Commission claimed it could not provide the texts. After repeated unsuccessful attempts to obtain the messages, The New York Times brought the matter before the ECJ in January 2023. The European Commission issued a statement in reaction to the ruling stating that they will now closely study the General Court's decision and decide on next steps. The executive will also "adopt a new decision providing a more detailed explanation" following the New York Times original request, the Commission said. "Transparency has always been of paramount importance for the Commission and President von der Leyen. We will continue to strictly abide by the solid legal framework in place to enforce our obligations," they added. With today's ruling, the Court has determined that the Commission has failed to adequately clarify whether the requested text messages were deleted and, if so, whether the deletion occurred deliberately or automatically. 'Every day there are a lot of interactions between the members of the Commission, all the members of the staff of the Commission, and external stakeholders,' said an EU official ahead of the ruling, adding that most of these interactions take place through emails, text messages and other applications and it would be materially impossible to register all these exchanges. The official said that it was wrong to suggest that Commission denied that text messages between the President of the Commission and the CEO of Pfizer existed, the executive had maintained that the exchanges did not contain important information. Under the EU's 2001 regulation on public access to documents, text messages qualify as "documents" and should be preserved and made available upon request, the New York Times had argued. The regulation defines a document as 'any content, whatever its medium (written on paper, stored in electronic form, or as a sound, visual, or audiovisual recording), concerning a matter relating to the policies, activities, and decisions within the institution's sphere of responsibility.' According to the Court, in this specific situation, the Commission cannot merely state that it does not hold the requested documents but must provide credible explanations enabling the public and the Court to understand why those documents cannot be found. For the EU judges, the Commission has not explained in detail the type of searches that it carried out to find those documents or the identity of the places where those searches took place. Accordingly, it has not given a plausible explanation to justify the non-possession of the requested documents. Furthermore, the Commission has not adequately clarified whether the requested text messages were deleted and if so, whether the deletion was intentional, automatic, or due to the replacement of the President's mobile phone in the meantime. The European Commission has two months to appeal the Court of Justice's decision.
Euronews
14-05-2025
- Politics
- Euronews
EU Commission loses on all counts in Pfizergate legal case
After a long tug-of-war between the European Commission and The New York Times over transparency surrounding the Pfizer COVID-19 vaccine contracts, the European Court of Justice (ECJ) today ruled that the Commission 'has not given a plausible explanation to justify the non-possession of the requested documents.' According to the Court, the Commission cannot simply claim it does not hold the requested documents; it must provide credible explanations that enable both the public and the Court to understand why those documents cannot be located. The ECJ found that The New York Times had submitted relevant and consistent evidence indicating the existence of text messages between the President of the Commission and the CEO of Pfizer regarding the procurement of COVID-19 vaccines. 'These contracts were totally unprecedented in a totally unprecedented context,' said an EU official ahead of the ruling. The publication uncovered the existence of the messages in 2021 during interviews with Bourla, but encountered obstacles when requesting access to them. The Commission claimed it could not provide the texts. After repeated unsuccessful attempts to obtain the messages, The New York Times brought the matter before the ECJ in January 2023. The Court has now determined that the Commission has failed to adequately clarify whether the requested text messages were deleted and, if so, whether the deletion occurred deliberately or automatically. The European Commission has now two months to appeal the Court of Justice's decision. This is a developing story.
Yahoo
30-04-2025
- Business
- Yahoo
Pfizer's Bourla ‘cautiously optimistic' on looming US pharma tariffs
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can't predict the impact of any tariffs or trade policy changes the Trump administration might impose on the pharmaceutical sector. 'While we continue to engage and plan for contingencies, we're focusing day to day on what we can do to move our business forward,' Pfizer CEO Albert Bourla said in remarks prepared for the company's earnings call for the first quarter. The drugmaker expects to earn between $61 billion and $64 billion in revenue this year, an estimate that doesn't include any provisional accounting for future tariff-related charges. Company CFO Dave Denton noted in a conference call, however, that it anticipates about $150 million in expense from already introduced general tariffs, which it believes it can absorb within its current guidance range. Some of Pfizer's industry peers, such as Johnson & Johnson and Merck & Co., have also shared initial estimates for the expenses they expect to incur as a result of the general tariffs President Donald Trump announced April 2, and then later partially paused for 90 days. Pharmaceutical products are exempt from those duties. However, his administration recently began a trade investigation that's widely expected to result in sector-specific tariffs on pharmaceuticals, potentially as soon as next month. Trump has hinted levies could range anywhere from 50% to 200%. The probe, known as a Section 232 investigation, is specifically meant to weigh national security risks, something that Bourla said was the primary concern voiced by administration officials in his conversations with them so far. 'We have had very productive discussions with all the secretaries that are involved,' said Bourla on a conference call Tuesday. 'I'm cautiously optimistic.' 'We will work with the administration to make sure that their concern on national security will addressed [in] the best possible way,' he added. In the meantime, Pfizer has put together an internal team to model possible trade policy outcomes and develop strategies, such as how the company manages product inventory levels, to lessen any impacts. Broadly speaking, the pharma industry relies on China and India for many of the raw starting materials used in the production of small molecule drugs, as well as for a good share of the active ingredients in those medicines. Many drugmakers also have extensive manufacturing in European countries like Ireland, Switzerland and the Netherlands. Bourla said he believes the Section 232 investigation will focus on countries 'unfriendly' to the U.S., which, if borne out, could suggest less punitive measures on countries like Ireland, where the industry also domiciles much of its intellectual property. In recent months, many of the largest pharma companies have announced plans for significant investment in U.S. manufacturing, moves that could eventually help reduce their exposure to supply chain risks like tariffs. Eli Lilly, for instance, in February said it would spend $27 billion to build four new U.S. factories at an event attended by Commerce Secretary Howard Lutnick, who oversees the Section 232 probe. Since then, J&J, Merck, Novartis, Roche, and AbbVie have disclosed plans for U.S. manufacturing investment that will total nearly $150 billion over the next decade. Pfizer, which has been cutting costs after over-expanding early in the COVID pandemic, hasn't unveiled a similar target. Speaking on Tuesday's call, however, Bourla said the company had substantial room in its existing U.S. facilities to expand production. 'We have huge manufacturing capacity right now in the U.S., particularly for everything that is injectable,' Bourla said. 'Our ability, if there is a need, is clearly there without the need to build new facilities, just utilize the current ones and transfer production there.' Overall in the first quarter, Pfizer reported $13.7 billion in revenue, down 8% from the same period last year due mainly to declining sales for the company's COVID antiviral Paxlovid. On an adjusted and diluted basis, earnings per share were $0.92, well above consensus Wall Street estimates as Pfizer's operating costs came in lower than expected. The company also shared plans to trim a further $1.2 billion in selling, informational and administrative costs by the end of 2027, as well as $500 million in R&D costs, which it plans to reinvest in its product pipeline. Combined with previously announced cuts to spending, Pfizer now expects $7.2 billion in net cost savings by 2027. Editor's note: This story has been updated to include mention of tariff-related expenses from non-pharmaceutical tariffs that Pfizer expects to absorb within its current financial forecasts. Recommended Reading US launches probe that could set stage for pharma tariffs Sign in to access your portfolio
