European Medicines Agency and Swissmedic Approve Pfizer’s COVID-19 Vaccine – Positioning Europe To Start Immunizations On Heels Of US, Canada, UK and Israel Medicines & Vaccines 21/12/2020 • 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) The Pfizer-BioNTech COVID-19 vaccine during the manufacturing process. The European Medicines Agency (EMA) announced on Monday that it would recommend conditional marketing authorization for the Pfizer/BioNTech COVID-19 vaccine – positioning Europe to finally begin rolling out vaccines across the continent – albeit after the United States, Canada, the United Kingdom and Israel have already moved into high gear vaccine campaigns. Mass vaccinations were set to begin next week in a number of countries across Europe – following the expected European Commission approval of the EMA recommendation later this week. Germany, France, Austria and Italy all said that they planned to start vaccination programmes for their most vulnerable groups beginning on Sunday 27 December. The EMA move was preceded by Swiss approval of the Pfizer vaccine on Saturday; like the EMA, the Swiss approval came earlier than previously expected. Mass vaccine campaigns of vulnerable, priority groups, will begin in Swizerland on 4 January, 2021, Swiss health authorities said. However, a spokesperson declined to provide details on the planned pace of vaccinations – saying only that Swiss authorities hope to immunize most of those who want the vaccine “by summer.” Emer Cooke, Executive Director of the European Medicines Agency. Originally set to meet on vaccine approvals in January, the high rates of infection coupled by the fast pace of rollouts occurring elsewhere – apparently inspired both the EMA and the independent Swissmedic regulatory agency to act earlier – although not with undue haste, an EMA official was careful to point out. “Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards,” said Emer Cooke, the newly appointed Executive Director of EMA – who only recently left the World Health Organization to assume the post. The Swiss approval also marked the first time that a COVID-19 vaccine had received a standard regulatory authorization. Since Switzerland has no emergency use or conditional approval process the normal process was the only one that could be followed – observers explained. Vaccine Rollouts – Race Against Mounting Infections The authorizations and vaccine rollouts coincide with mounting levels of infections and death rates in many parts of Europe, despite successful infection control campaigns over the spring and summer. Concerns have now risen further with the discovery of a new, and more contagious variant of SARS-CoV2 in Britain, South Africa, leading to travel bans and flight cancellations (See related story). It is still too soon to know if the vaccines being rolled out now will be as effective against the new coronavirus variant as they have proven to be against those prevalent until now. But experts are hopeful that the recently-approved vaccines will meet the test. “We don’t yet have evidence with respect to the new strain, whether it is susceptible to the antibodies generated by the vaccine,” said Cooke at the EMA press briefing. “However, we have quite broad knowledge around the fact that this vaccine is capable of generating neutralizing antibodies that can neutralize the different variants with mutation within the receptor binding domain, which is the key area for attachment to the cells in the human body. “So we think that, even if we don’t yet have full confirmation, it is very likely that the vaccine will retain protection, also against this new variant.” “In principle, what would scare us would be if we see multiple mutations, particularly on this spike protein and on the receptor binding domain that will really alter the antigenic profile of the virus with respect to these vaccines and render them incapable of neutralizing the virus,” said Marco Cavaleri, Head of Anti-infectives and Vaccines, Scientific and Regulatory Management Department at EMA. 3D print of a spike protein on the surface of SARS-CoV-2, enabling the virus to enter and infect human cells. “We will need to see the virus changing quite substantially before we can really be in a situation to see…think [about] whether the vaccine has to be somehow rebuilt, incorporating new emerging strains. So, for the time being, we are not too worried.” Next In Line – Moderna Vaccine The EMA is planning on announce its recommendations on a second vaccine, produced by Moderna, on January 6. Meanwhile, in the United States, transportation and delivery of the Moderna vaccine to hospitals and health centres had already begun following its emergency use authorization by the US Food and Drug Administration (FDA) on Friday. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said Stephen Hahn, US FDA Commissioner, in a press release. The US Department of Health and Human Services has purchased 200 million doses of the Moderna COVID-19 vaccine, which will provide for continuous delivery of the vaccine through the end of June 2021. The vaccine, based on the same mRNA delivery technology as the Pfizer vaccine is less temperature sensitive – it can remain stable for long periods at temperatures of -2 -8 C as compared to Pfizer’s -70 C storage requirement. Israel’s Prime Minister – First Head of State Immunized in COVID-19 Vaccine Rollout Meanwhile, while the United States has seen Vice President Mike Pence immunized as well as President-elect Joe Biden, Israeli Prime Minister Benjamin Netanyahu was likely the first serving head of state to publicly receive an approved Pfizer-BioNTech vaccine jab in a televised broadcast Saturday night. Israeli Prime Minister Benjamin Netanyahu receiving the Pfizer-BioNTech vaccine on Saturday. “I asked to be vaccinated first, together with Health Minister Yuli Edelstein [Minister of Health], to serve as personal examples and encourage you to be vaccinated,” said Netanyahu. “It’s one small shot for a person and one big step for everyone’s health.” Netanyahu – with his government crumbling and personally under assault from both the left as well as the right – has sought to take credit for procuring enough doses of the Pfizer and Moderna vaccines to immunize almost all of Israel’s 9 million citizens. The Ministry of Health announced that the vaccine operation would rollout in stages, beginning with health care workers, high risk populations, and those of 60 years of age. According to preliminary reports, approximately 10,000 medical staff members were vaccinated on Sunday. “I am pleased to announce that on the first day of Operation ‘Latet Katef [to give a shoulder]’ there is an excellent response by medical staff throughout the country and that starting yesterday afternoon, public pressure to get vaccinated was sensed,” said Hezi Levy, Director General of the Ministry of Health. “We will vaccinate everyone…the Operation progresses on the move.” The campaign received immediate uptake with appointment hotlines crashing as Israelis clamored to set appointments to be vaccinated. While limited right now to health workers and people over the age of 60, the gates will be opened to everyone over the age of 16 within a couple of weeks. The rapid timetable set by the government should see some 60,000 Israelis vaccinated a day for coming months – with the hopes of reaching herd immunity of 60% immunized by spring. What was less clear, however, was the timetable for vaccinating some 3.5 million Palestinians in the West Bank and Gaza – who are not members of the Israeli health funds that are running the vaccine campaigns. In addition, the nearly 2 million Palestinians living in the Hamas-controlled Gaza Strip have been subject to a longstanding Israeli boycott, making the transport of temperature sensitive vaccines in and out of the Gaza strip even more challenging than usual. And even in the more affluent Palestinian West Bank – home to some 3 million Palestinians – there is reportedly only one vaccine refrigerator capable of managing the ultra-cold storage required for the Pfizer vaccine. Dr. Ali Abed Rabbo, a senior Palestinian health official, told media that Palestinian Authority will rely largely upon the WHO- supported COVAX global procurement initiative to eventually get vaccines to their communities – which are currently under lockdown due to high COVID-19 infection rates. Through COVAX, WHO hopes to distribute vaccines to some 10-20% of people in low- and middle-income countries, beginning in the first quarter of 2021. At the same time, Israeli Deputy Health Minister Yoav Kisch told the local Kan Radio station that Israel might consider allocating some of its vaccine supply to the Palestinian areas – if sufficient quantities are available after most of Israel’s nine million citizens are vaccinated – a population that includes some 20% Arab Muslim, Christian and Druse minorities. “Should we see that Israel’s demands have been met and we have additional capability, we will certainly consider helping the Palestinian Authority,” he told Israel’s Kan Radio station. Like many other things in the Israeli-Palestinian conflict, the vaccine issue casts into sharp relief the broader and more global distributional divide between high income and lower or middle income countries vis a vis vaccines – in a particularly up-close way. It also illustrates, however, how vaccine sharing may also be, ultimately, in self- interest of higher-income countries – including communities in conflict zones. Since Israeli settlers are scattered across the occupied West Bank, while tens of thousands of Palestinians work in settler-owned enterprises or in Israel proper – in the absence of vaccine sharing with the Palestinians, the goal of herd immunity will be that much harder for Israel to attain. Image Credits: European Commission, Pfizer, European Medicines Agency, Flickr – NIAID, Youtube – Israeli PM. 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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