Pfizer COVID-19 Vaccine Makes It First To Finish Line; United Kingdom Authorizes Today & Rollout Begins Next Week Medicines & Vaccines 02/12/2020 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Clinical trial volunteer receives injection of vaccine candidate developed by Pfizer and BioNTech. Pfizer’s COVID-19 vaccine, a cutting edge mRNA technology produced jointly with the German firm BioNTech, was authorized for use on Wednesday by the United Kingdom – making it the vaccine the first to be rolled out for commercial public use as early as next week. The vaccine was authorised Wednesday morning for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA), eight days before the US FDA is expected to meet on the Pfizer application for regulatory approval there, while the timeline for broader European approval of Pfizer’s candidate, as well as a similar Moderna vaccine, may not come until early 2021, with the European Medicines Agency set to meet 12 January. The timeline for vaccines approval and distribution elsewhere in the world is expected to follow after the US FDA and EMA approvals. But massive distribution of COVID vaccines in many low- and middle-income countries still depends on rapid approval of a much cheaper AstraZeneca vaccine type, which uses a more conventional immunization strategy, in the form of a weakened adenovirus, to deliver a fragment of SARS-CoV2 viral protein and stimulate immunity. It can also be storaed in a refigerator, unlike the Pfizer and Moderna vaccines that require freezer or deep freezer storage. The UK’s Department of Health and Social Care announced, its approval of the Pfizer vaccine, following a review of the MHRA’s recommendation. The MHRA was vested with the power to approve new COVID vaccines under special governmental regulations in force ahead of 1 January 2021, when the medicines agency will become fully responsible for medicines authorisation in the UK following Brexit. “The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use,” stated the government announcement. “This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.” A UK Department of Health and Social Care spokesperson said: “The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination. The Department urged the public to continue to abide by current COVID-19 restrictions, saying: “To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.” UK authorities said that they had some 40 million doses on immediate order and 800,000 doses ready to deploy over the next few days. Global Health Leaders in UK and World Welcome Step The reaction from UK and global health leaders was swift: WHO’s Dr Tedros Adhanom Ghebreyesus said in a tweet: “This is the first country to authorize the Pfizer/BionTech #COVID19 vaccine for emergency use and expects to start rolling it out as soon as next week. “ Chris Whitty, Chief Medical Officer, United Kingdom. England’s Chief Medical officer, Chris Whitty, warned that the approval doesn’t mean that people should begin relaxing social distancing and other COVID-19 prevention measures yet. “This is excellent news and a step towards normality,” he said, but added, “It will take until spring until the vulnerable population who wish to are fully vaccinated. We can’t lower our guard yet.” Professor Sir Robert Lechler, President of the UK Academy of Medical Sciences, called it, “brilliant news and a historic moment providing a light at the end of a gloomy tunnel. “This vaccine is an example of the extraordinary power of biomedical science demonstrating how medical research has played a vital role in helping us understand and respond to this virus. It will take time to achieve mass vaccination so we must not relax our guard against COVID-19 yet, in fact now is the time to strive to stay safe more than ever. “The Pfizer-BioNTech COVID-19 vaccine does come with challenges such as storage at around -70C which is why I am pleased that there are other promising vaccines that could be approved for use soon, and I look forward to more good news within the comings months. “To ensure good uptake of COVID-19 vaccines it is essential that public health messages around vaccination reach all parts of society, regardless of age, socio-economic background, ethnicity or language. The best way to do this is work hand in hand with different communities to understand the questions they have, to co-produce effective messages and understand the best ways to share them. He also urged that people continue practicing measures to prevent infection, saying: “This vaccine is a fantastic new tool in our defences against the virus, but we all still have a part to play in preventing the spread of COVID-19. I urge everyone to keep sticking to the measures, including the use of face coverings, social distancing, following the guidance on tier restrictions and isolating when sick. It is vital we all stay healthy to enable the NHS to support the roll out of this new vaccine.” The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) called it “good news for people in the UK, especially the health care workers, the elderly and people who have underlying medical conditions… It is also good news in terms of scrutiny that the vaccine is safe and effective; based on clinical trial testing designed to represent all races, genders and ages, as well as people with medical conditions.” UK Approval is ‘Huge Step’ – But For The Entire World – We Will Need A Range of Vaccines That Work Across Different Groups & Settings Dr Charlie Weller, Head of Vaccines at the UK-based Wellcome Trust, described the announcement as “historic day and an important moment at the end of an incredibly difficult year. For a vaccine to be developed, receive emergency approval and be ready to roll out in less than a year for a new virus is completely unprecedented. The speed of development for this and other vaccine candidates is testament to an extraordinary, collaborative, global research effort. “As normal for any vaccine, there will be a need for close and continued monitoring for safety and efficacy as it is delivered. We will also need to continue tracking and improving our understanding on how long the protection lasts. We must recognise that not everyone will have a vaccine immediately or even early next year. It is critical that groups most at risk, such as the elderly and frontline healthcare workers, are prioritised to receive the first doses. But while the decision “clears the path for this vaccine to be rolled out to a wider population, there are now important considerations and significant logistical hurdles ahead. We have never attempted to roll out any vaccine at this sort of scale and at this sort of speed anywhere in the world,” Weller said. Wellcome is a major player in the WHO’s ACT Accelerator global drugs and vaccines distribution initiative, as well as funding R&D on a range of other COVID-19 vaccines, considered necesary to attain broad global coverage: And while the UK decision signals: “a huge step forward to end the pandemic… if we are to have enough doses for the entire world, we will need a range of vaccines that work across different groups and settings. It is therefore vital there is continued global investment in developing a wide range of candidates. Alongside vaccines, we will need effective treatments, tests and most of all global collaboration, to overcome COVID-19.” “Ït’s going to be extremely frustrating, Modern CEO Admits – There Won’t Be Enough for Most People In the World Right Away Stéphane Bancel, Chief Executive Officer, Moderna. Said Stéphane Bancel, Chief Executive Officer, Moderna, in an interview with the World Economic Forum late Wednesday afternoon, his company is on track to produce 500 million to a billion doses of its mRNA vaccine next year. The vaccine, which has less demanding cold storage requirements than Pfizers, is suitable to be shipped and used in many, if not, most places of the world. And in terms of the trial results, “the piece I got the most excited about when I got the data from my team was that we had 30 severe cases, and all 30 were in placebo – meaning that if you get the vaccine, you probably will have no disease symptoms, but if you have any sign of the disease, it will be a very mild disease…. And as we know, what has had a big impact on human life, public health and economy is a cascade of severe diseases, and death, which has driven the lockdowns, social distancing and all the suffering and mental suffering that that we know as is going on as we speak.” He also publicly credited the US$ 1 billion in US government funding that supported Moderna’s clinical trials as “being very helpful” in lowering the price the company will finally charge for the drug. “It is going to help, of course, in terms of affordability and access around the world, because the US basically picked up the tab to pay for the development of a product.” Still, while Bancel said his company was on track to have “20 million doses” of the Moderna vaccine ready to go before the end of the year, he also admitted that the speed at which global vaccine distribution unfolds is likely to be initially “extremely frustrating for the general population, how slow it is going to feel . .. because there won’t be enough for most people in the world, definitely in the first quarter, definitely in the second quarter, and most probably for the entire year – if you are worrying about people around the world and not only in rich countries. “We know that in rich countries, not only people have cash, but they also have less people,” Bancel said. “Aand so it’s a math problem… of just numbers of people that you need to vaccinate, and so I think that around the world, it is going to be very frustrating that people will want to get the vaccine… I think there’s going to be a lot of people wanting a vaccine very quickly to get back to normal life.” AstraZeneca Says Its Vaccine Will be Low Cost & Sturdy Mene Pangalos, Executive Vice-President, Biopharmaceutical Research and Development, AstraZeneca. On a more positive note, Mene Pangalos, Executive Vice-President, at AstraZeneca, said that the company’s vaccine, which is less temperature sensitive and is to be priced as low as $US 3 per dose, is poised for deployment early in 2021, and “will make a dent” in the pandemic, along with the Pfizer and Moderna vaccines. Said Pangalos: “We have, as part of our commitment to helping deal with a pandemic, committed to doing and delivering and supplying the vaccine during the pandemic, not for profit. And we have around 3 billion doses, ready to go. By the end of, 2021, many of those several hundred million of those doses available in the first quarter of next year. “So I do think with the data we have, we have a vaccine that is approvable that will make a dent in the pandemic along with vaccines from from Pfizer and Madonna. And I think the supply as early in the year as possible around the world is going to be very important to try and make the dent that we need, on this virus and getting us all back to some normality,” he said. Henrietta Fore, Executive Director, United Nations Children’s Fund (UNICEF). Along with vaccine costs and production, the logistics of mass, worldwide vaccine distribution are unprecedented, said UNICEF’s executive director, Henrietta Fore, also appearing at the WEF event. She spoke about the importance of supporting the WHO co-sponsored COVAX vaccine initiative to reach the highest risk groups worldwide with new COVID vaccines by end 2021: “Currently, UNICEF procures and delivers about 2 billion vaccines doses, a year,” Fore said. “And that is to cover primarily childhood diseases… but COVAX is now asking us to double that number for next year,” she said, referring to the COVAX goal to distribute up to 4 billion vaccine doses, so as to reach 2 billion people next year with the two-dose vaccines. “And it’s to the lowest and the middle, low income countries so it’s the hardest places. So the challenge is enormous. It’s got to be a big public private partnership.” Help is needed to streamline supply chains and as well as cold chains, she added: “Currently we are used to vaccines that can move in relatively cool temperatures but not ultra-cold,” she said referring to the Pfizer vaccine that needs -70 C storage along with Moderna’s counterpart, which requires at -20 storage long term, and -2 to -8 C for a month. “We need supply chain logistics and transportation sectors that are all working together, we need to prioritize the transportation of vaccines, so that in the lessened amount of cargo space that we can get the vaccines out there and across the boundaries and into the countries.” Fragile health systems also need to be bolstered, said Fore, “we really have to think about the fragility of many of these countries, health systems. We’ve been just working on that in Sudan recently.. in the poorest countries it’s particularly important – financial support, technical support and equal investment in the systems that will deploy COVID-19.” Public Funds Also Poured Into Pfizer/BioNTech Vaccine While more attention has been given to the public funding accorded to the startup Moderna, the German government in September paid up to € 375 million to BioNTech to help speed up the development of the Pfizer-BioNTec mRNA vaccine. That followed a European Investment Bank loan of €100 million in June to “allow the company to expand its manufacturing capacity in order to supply the vaccine fast worldwide in response to the pandemic.” As a result of the public funding, the price per dose for the BioNTech/Pfizer vaccine in Europe will reportedly be about US$ 18.34, according to a recent Reuters report. That is about a US$1.20 less than the reported US$19.5 the United States reportedly agreed to pay in July, when it purchased 100 million doses, with an option to buy a further 500 million under terms to be negotiated separately. Pfizer said only that the company is using a tiered pricing formula based on volume and delivery dates, and that the EU deal had represented the largest initial order of its vaccine candidate to date. “We are not disclosing further details of this agreement,” it added. Medicines access advocates are quick to point out that despite the hundreds of millions of dollars in public funds that have been poured into both the Pfizer BioNTech project, as well as a similar Moderna vaccine, prices of both that will be charged to governments have remained closely guarded secrets. In addition to the late-stage research grants and loans, the foundational research into the mRNA vaccine delivery mechanisms was also publicly supported, access advocates have pointed out. That work, carried out by two researchers, Katalin Karikó and Drew Weissman, at the University of Pennsylvania, received US government funding, according to an analysis of the R&D funding by Knowledge Ecology International (KEI). Karikó and Weissman later licensed their inventions “non-exclusively” to Moderna and BioNTech RNA, the company that has been collaborating with Pfizer for the development of a mRNA vaccine. But due to its investment, the US government still holds some rights to six of the 11 patents that were instrumental in developing the mRNA vaccines of both companies, KEI’s Thiru Balasubramaniam observed that the transparency of COVID-19 vaccine prices could also emerge as a flashpoint in discussions that will get underway Thursday among WHO member states, in light of the streams of public funding that has gone into vaccines development, . The member states are meeting to discuss pharma’s R&D costs and medicines shortages, in the context of a renewed push to implement the WHO’s Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property. “President Trump prides himself on being the consummate negotiator. He wrote ‘The Art of the Deal’; he didn’t get such a good deal here,” observed Balasubramaniam. Meanwhile, he said, referring to the UK’s approval today: “the heirs of Hengist and Horsa are first in the queue.” Image Credits: Pfizer, BioNTech, Number 10, WEF. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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