Pfizer and Moderna are likely to be the first companies to see their respective vaccines authorized in the United States, possibly before the end of 2020. Though their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different. Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market. Yet when the COVID-19 pandemic began, both companies bet big on a brand-new vaccine technology called mRNA. Moderna had been working on the technology for years, while Pfizer partnered with a smaller German biotechnology company BioNTech for its mRNA research.
After rapidly testing their vaccines in early-stage studies, Pfizer and Moderna launched their massive Phase 3 trials, which is the last step before authorization, on July 27, 2020. And the companies have been neck in neck since then, with Moderna ultimately emerging with key data milestones about a week behind Pfizer because of subtle differences in its trial design and vaccine dosing.
The U.S. is the second-biggest producer, at 27%, but its bulk contracts with manufacturers keep doses produced in the U.S. from leaving.The global supply of the Pfizer/BioNTech vaccine is coming from the EU, which is exporting 48% of its production, vs. 0% from the U.S. according to Airfinity, a science information and analytics company.Moderna is using its European facilities to supply Canada with doses, because all doses produced at U.S. sites are going toward the 300 million the U.S. has purchased. The Biden administration took a tentative first step last week, offering around 4 million total doses of the Oxford/AstraZeneca vaccine — which isn’t authorized for use in the U.S. — to Mexico and Canada. The administration has also pledged $4 billion to the global COVAX initiative and more still to help increase supplies to Asia. But it’s holding tight to virtually every dose produced in the U.S. "We're going to have excess supply," said Zeke Emanuel, vice provost for global initiatives at the University of Pennsylvania, who was a member of Biden’s coronavirus task force during the transition.
Pfizer declined an initial research investment from the US government’s Operation Warp Speed, a multibillion-dollar program to accelerate the development and distribution of COVID-19 vaccines. But Moderna has been partnered with the government from the start, enjoying a longstanding research collaboration with the National Institutes of Health, accepting $955 million in funding from the Biomedical Advanced Research and Development Authority (BARDA). Both companies have accepted Operation Warp Speed funding in exchange for a promise that the first 100 million doses of their respective vaccines will be delivered to the U.S. government. And when it comes to their vaccines, both Pfizer and Moderna’s are quite similar.
Days Left by Country Until Herd Immunity to Covid-19 is Reached Through Vaccinations Around the World
“They’re using something called an mRNA technology, which is relatively new in vaccine development,” said Azra Behlim, senior director of pharmacy sourcing and program services at Vizient.
Compared to some other vaccine technologies, mRNA is a more delicate product, Behlim told ABC News, meaning it needs to be kept frozen for long term storage. Moderna’s vaccine can be kept in normal freezer temperatures, like the freezer you have at home. Pfizer’s vaccine, meanwhile, must be kept in a specialized ultra-cold freezer at -94 degrees Fahrenheit. Once thawed, the Moderna vaccine can be kept in a normal refrigerator for a month, while Pfizer’s can only be kept in a typical fridge for five days.
“Some of those cold chain storage issues that the Pfizer vaccine brought up ... could be alleviated with [Moderna's] vaccine,” said Dr. Colleen Kelley, associate professor of medicine at Emory University School of Medicine and principal investigator for the Moderna study at the Ponce de Leon Center. “This is good news for places that may not have access to that ultra-cold storage,” said Kelley. That could include more rural parts of America. Operation Warp Speed Vaccine Development Lead Dr. Matt Hepburn said, "the fridge-for-a-month distribution point we made really enables for a much more distributed model to get the vaccine out there, potentially for example in very rural areas."
But with limited supplies of each vaccine available at first, enough to vaccinate only 20 million Americans by the end of the year, experts agree the U.S. needs multiple vaccines to fight the pandemic. That includes not only Pfizer and Moderna's vaccine but also even more that are further behind in development. Two other companies that received funding for clinical research from Operation Warp Speed -- AstraZeneca and Johnson & Johnson -- had brief setbacks when their late-stage trials were paused over safety concerns. But those trials are now back up and running and may have data available in the coming weeks and months. “We will not see the other side of this pandemic without an effective vaccine, and multiple effective vaccines,” Kelley said.
FDA Advisory Panel Endorses Third Covid-19 Vaccine - Johnson & Johnson - for Emergency Use - 2 26 2021
Johnson & Johnson’s one-dose COVID-19 vaccine appeared safe and effective in trials, the U.S. Food and Drug Administration said, paving the way for its approval for emergency use on February 26, 2021. The vaccine was 66% effective at preventing moderate to severe COVID-19 in a 44,000 person global trial, the FDA said in documents ahead of a Friday meeting of independent experts who will advise the agency on emergency authorization. New data provided by J&J to the FDA showed the vaccine was 64% effective at stopping moderate to severe cases of COVID-19 after 28 days in thousands of trial participants in South Africa where a worrying new variant has swept across the country.
Overall, the vaccine was 100% effective at stopping hospitalization 28 days after vaccination, compared with 85% at 14 days, and there were no COVID-19 deaths among those who received the shot rather than a placebo. J&J also said the data suggested its vaccine cut down on asymptomatic infections, which experts said was another sign COVID-19 vaccines may indeed stop transmission of the disease.
“Most encouraging to me were the data in South Africa,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA advisory committee that will make its recommendation on Friday. “That you could still get protection against medically attended illnesses - meaning hospitalization, ICU admission and deaths from that vaccine against the South African strain, I thought that was really encouraging.”
The vaccine is administered in a single dose and can be stored in normal fridges, in contrast to the Pfizer and Moderna shots which need two doses and must be kept in freezers. The J&J vaccine is also considered essential in the global vaccination effort due to its routine storage requirements and is already being rolled out to 500,000 healthcare workers in South Africa. J&J said in documents submitted to the FDA that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate. While fighting asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease. “The data is consistent with the fact that these coronavirus vaccines, including the J&J vaccine, do have an impact which is significant on asymptomatic spread,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
However, he said some public health authorities may ask to see more robust data before being persuaded. The effectiveness of the one-dose vaccine varied over time. In Brazil, where a similar variant to the one in South Africa is circulating, the vaccine was 66% after 14 days, rising to 68% at 28 days. In the United States, the effectiveness fell from 74% at 14 days to 72% two weeks later. Overall, only two vaccine recipients developed COVID-19 severe enough to need medical intervention after 14 days and that dropped to zero after 28 days. J&J has said it sees rising immunity from its vaccine until at least 28 days after injection. The drugmaker has said it expects sustained - or even improved - protection over time.
SIDE EFFECTS: Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization. The FDA said the most common reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine. The regulator said one case of pericarditis, a heart disease, may have been caused by the vaccine. It said cases of a rare disorder, Guillain-Barre Syndrome, were unlikely to be related to the shot though data was insufficient to determine whether the vaccine had caused these side effects.
AstraZeneca’s U.S. Trial Shows Coronavirus Vaccine is 79 Percent Effective
Oxford researchers, who developed the easily transported $4 shot for the British-Swedish pharmaceutical giant AstraZeneca, said their coronavirus vaccine is “safe and highly effective, adding to previous trial data from the United Kingdom, Brazil and South Africa, as well as real-world impact data from the United Kingdom.” An independent monitoring board combed through the data to look for any cases of blood clotting events similar to those that caused the vaccination effort to be suspended in many European countries. While vaccination was started again after a pause, it undermined confidence in the vaccine. The independent board found no suggestion that the vaccine carried an increased risk of clotting. The trials included 32,449 adult participants in all age groups, most of them in the United States. The volunteers received either two standard doses of the Oxford-AstraZeneca vaccine or a placebo, at a four-week interval, the researchers said.
The company said in its release it will apply for emergency authorization from the Food and Drug Administration “in the coming weeks,” but a question that has emerged recently is whether the United States, which President Biden has promised will have enough vaccine for all adults by the end of May, will need the vaccine. Fauci said it was too soon to know how it would fit into the U.S. vaccine portfolio “The one thing that one can say for sure, that this is good for the world, because it’s a cheap vaccine. It’s got good results. They will likely be able to produce enough for a lot of different countries,” Fauci said.
The Oxford researchers said that the Data and Safety Monitoring Board in the United States “reported no safety concerns among the participants receiving at least one dose of the vaccine.”The results were reported in a pair of brief news releases from the pharmaceutical company and the university scientists. The drug company said, “vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.” The U.S. government has preordered 300 million doses of the AstraZeneca vaccine.
The FDA has already given emergency authorization to vaccines from U.S. firms Pfizer, with German partner BioNTech; Moderna; and Johnson & Johnson. The Pfizer-BioNTech and Moderna vaccines, which require two doses, have shown up to 95 percent efficacy against symptomatic covid-19. The Pfizer-BioNTech vaccine requires special handling and must be kept at especially cold temperatures in special freezers.
An Israeli-American pharmaceutical company is preparing to launch a Phase I clinical trial for what could become the world’s first oral COVID-19 vaccine. Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company based on technology developed by Hadassah-University Medical Center, announced over the weekend a joint venture with Premas Biotech to develop a novel oral vaccine. Together they formed the company Oravax Medical Inc. The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology.
As Society Looks to Rebound from Covid-19 the Ideas and Resources we Need to Cope and
Succeed will Look Different Than Before
How will People Change and Grow in the Wake of the Pandemic? As human beings, we all share the same sorrows, the same hopes, the same potential. The Covid-19 pandemic has reminded us how interdependent we are: what happens to one person can soon affect many others, even on the far side of our planet. Therefore, it is up to all of us to try to cultivate peace of mind and to think about what we can do for others, including those that we never see. It is natural to feel worry and fear at a time when so many are suffering. But only by developing calmness and clear-sightedness can we help others and, in so doing, even help ourselves. In my own life, I have often found that it is the most difficult challenges that have helped me gain strength. The current global health crisis also reminds us that what affects the human family has to be addressed by all of us. The solution to this, as to many other problems, especially concerning the environment, depends on international co-operation. Ultimately, if humanity is to thrive, we must remember that we are one.
In-person, mask-free interactions seem like a thing of the past, but will eventually return, as the importance of face-to-face relationships has become very clear in past months. Early in the Covid-19 pandemic, as countries jostled for test kits and protective equipment, global supply chains imploded, and low-income countries found themselves at the back of the queue. The World Health Organization (WHO), working with United Nations partners, developed a procurement platform. The region now has more than 750 laboratories able to test for the virus. However, many low-income African countries are still struggling with a distorted market and less than optimal testing rates. Ensuring access to a Covid-19 vaccine is potentially an even greater challenge. The speed of vaccine development has been extraordinary and it’s likely that we will have a viable vaccine in record time.
Relationships continue to be strained as social distancing and lockdowns stretch into 2021, causing some experts to worry about loneliness stemming from isolation. The pandemic has ruptured work for millions of people across the globe, leading to a painful period of uncertainty and anxiety. Being able to work is central to many aspects of life: survival, capacity to contribute and achieve, social connections and self-determination. This crisis is exposing the impact of the lack of protections and support for working people, which is now painfully clear. Because of the porous safety net that has allowed so many people across the globe to experience food, housing and health insecurity, I believe that this moment offers an inflection point.
In addition to mental health challenges, the pandemic has also revealed challenges in our systems and institutions, which were already riddled with inequalities and problems. Presently, however, the pandemic is undisputable, causing suffering and deaths across the world. The question then arises as to how this could happen, and various forms of fake news and unrealistic narratives have flourished, in social and other media. Some argue in favour of increased nationalism, blaming globalisation for the pandemic. Other arguments are also seen, such as ‘nature fights back’, providing ‘nature’ with social agency. Rather than adhere to conspiracy theories, nationalism, mysticism or other kinds of anti-intellectual attitudes, we need to return to the core ideas of the Enlightenment, questioning all kinds of orthodoxies, political and religious, and emphasise the scientific method (to develop vaccines) and international collaboration (to disseminate the vaccination programs) as the only way out of the crisis.
Wellbeing and happiness need to be bigger priorities for everyone in society, experts say. Hidden behind face masks, distanced six feet apart, we are quite literally losing touch with one another – starved of the social connectivity and engagement that is the very marrow of urban civic life. We turn instead to the echo chambers of social media, immersing ourselves in a sad simulacrum of the city – a kind of subdivision in the ether where we encircle ourselves with only those who look and act and think the way we do. Now the pandemic has revealed in stark relief what those of us who have studied economic inequality already knew: Covid-19 laid bare the vast network of underlying fragilities that continues to threaten the health and well-being of the United States. The latest economic research shows the many ways that high inequality – in incomes, wealth, and across firms – serves to obstruct, subvert, and distort the processes that lead to widespread improved economic well-being.
Travelling will likely be profoundly different for the foreseeable future, experts say, including who'll be able to travel and where they'll be able to do it. In the travel game, it’s tough even to understand what’s going on in the present. Some countries (Australia) won’t let people out, other countries (America) won’t let people in, even when they’re coming from a place with a better virus story. Or you can leave (the UK) and go somewhere else (the list changes daily) only to find (typically at 4 a.m.) all sorts of restrictions on your return. None of this encourages travel, and it’s probably a safe bet that merely making the decision to head for the departure gate is going to be a fraught choice for some time to come.
Quite apart from dealing with the bureaucracy and rules, I’m afraid that post-pandemic travel will be to a very different new world. Will we be welcomed? Will we be safe? And can we afford it? It will be a sad new world if travel becomes something only for the rich and gap-year travel becomes a rite of passage that ceases to exist. Of course, a travel reassessment will give us the opportunity to tackle some of the industry’s inevitable drawbacks from a fresh perspective, but will we tackle overtourism and climate change, or just turn the power back on and hit restart? Fewer planes are flying through the sky in the age of Covid, and the ultimate fate of the travel industry remains unknown and hanging in the balance.
Urban living may be replaced with remote work in suburban or rural areas. But the city dwellers to stay put will grapple with continued, Covid-underscored inequalities. Without a doubt, the ways we used to explore and engage while travelling have changed drastically. As we are now living with Covid, it is imperative that destinations, hotels, attractions, airlines – really the entire global tourist industry – continuously innovate solutions to meet the needs of “Gen-C”, the post-Covid generation. Our communal experience is driving changes to lifestyle and safety requirements for the new way of travelling. At the forefront is restoring traveller confidence and communicating how adjustments are impacting travel experiences at the local level. The heart of this is creating and marketing experiences that lend to stress-free travel within this new world.
The biggest unknowns in a post-pandemic work world. It’s been nearly a year since the novel coronavirus began spreading around the world. While we’ve learned a lot about Covid-19 since January – and how to live and work in lockdown – there’s still much we don’t know about how the pandemic will change our societies. What Covid-19 has brought “is a mindset difference that allows people to view remote work as a new normal rather than an occasional opportunity”.
Covid-19 will likely have permanent effects on the way we work. But the way we live, socialise and move about the world will be different, too. Covid-19 is a test like no other. Never before have the lives of so many people around the world been affected at this scale or speed. Over the past six months, thousands of AI innovations have sprung up in response to the challenges of life under lockdown. Governments are mobilising machine-learning in many ways, from contact-tracing apps to telemedicine and remote learning. However, as the digital transformation accelerates exponentially, it is highlighting the challenges of AI. Ethical dilemmas are already a reality – including privacy risks and discriminatory bias.
This undated file photo issued by the University of Oxford, shows of vial of coronavirus vaccine developed by AstraZeneca and Oxford University, in Oxford, England. Britain has authorized use of a second COVID-19 vaccine, becoming the first country to greenlight an easy-to-handle shot that its developers hope will become the “vaccine for the world.” The United Kingdom government says the Medicines and Healthcare Products Regulatory Agency has made an emergency authorization for the vaccine developed by Oxford University and UK-based drugmaker AstraZeneca. (John Cairns/University of Oxford via AP, File)
Britain on December 30, 2020, became the first country to authorize an easy-to-handle COVID-19 vaccine whose developers hope it will become the “vaccine for the world.” The approval and a shift in policy that will speed up rollout of the vaccine in the U.K. come as a surge in infections threatens to swamp British hospitals. The Department of Health said it had accepted a recommendation from the Medicines and Healthcare Products Regulatory Agency to authorize emergency use of the vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca. “The rollout will start on Jan. 4 and will really accelerate into the first few weeks of next year,” British Health Secretary Matt Hancock told told Sky News. Britain has bought 100 million doses of the vaccine.
AstraZeneca chief executive Pascal Soriot told BBC Radio 4 the company could start shipping the first doses of the vaccine Wednesday or Thursday “and the vaccination will start next week and we will get to 1 million — and beyond that — a week, very rapidly.” Hundreds of thousands of people in the U.K. have already received a different vaccine, made by U.S. drugmaker Pfizer and German firm BioNTech. Soriot said it was “an important day for millions of people in the U.K. who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.”
Oxford Institute - England
Coronavirus vaccines have typically been given in two doses, with an initial shot followed by a booster about three weeks later. But in a change of approach, the British government said that with the AstraZeneca vaccine it would prioritize giving as many people as possible a single dose, which is believed to give a large measure of protection against the virus. It said people at the highest risk would get priority, and everyone would get a second jab within 12 weeks of the first.The new strategy comes against a backdrop of soaring infections in the U.K. The number of hospitalized COVID-19 patients has surpassed the first peak of the outbreak in the spring, with authorities blaming a new, more transmissible variant of the virus, first identified in southeast England, for the spike.Oxford University’s Dr. Andrew Pollard, one of the leaders of the development team, offered hope the newly approved vaccine will help. “At the moment, there’s no evidence that the vaccines won’t work against the new variant,” Pollard told Radio 4. “But that is something which we have to look at. We can’t be complacent about this variant or perhaps future variants.”Partial results from studies in almost 24,000 people in Britain, Brazil and South Africa suggest the shots are safe and about 70% effective for preventing illness from coronavirus infection. That’s not as good as some other vaccine candidates, but Soriot recently told the Sunday Times newspaper that he was confident the vaccine would prove as effective as its rivals.
The Oxford-AstraZeneca vaccine is expected to be relied on in many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage some other vaccines require. The company has said it will sell it for $2.50 a dose and plans to make up to 3 billion doses by the end of 2021. “We have a vaccine for the world,” said Pollard. Researchers claim the vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people — too few to be conclusive. Questions also remain about how well the vaccine protects older people. Only 12% of study participants were over 55 and they were enrolled later, so there hasn’t been enough time to see whether they develop infections at a lower rate than those not given the vaccine. Researchers also were criticized for lack of information in September, when studies were suspended because a participant suffered a serious illness. AstraZeneca initially declined to provide further details due to patient confidentiality.
Ultimately, the trials resumed after regulators reviewed safety data and decided it was safe to continue. Published partial results show no hospitalizations or severe disease among those who received the vaccine. A separate study testing the AstraZeneca vaccine in the U.S. also is underway. The vaccine will become the second COVID-19 vaccine in use in Britain. On Dec. 2, regulators gave emergency authorization to the Pfizer-BioNTech vaccine. Having another vaccine available means that more people can get protection, said Sarah Gilbert, an Oxford scientist involved in the AstraZeneca project. It takes a different approach than the Pfizer-BioNTech one or another developed in the United States from Moderna Inc. The ultra-cold storage those other vaccines need is “very impractical” in developing countries, said Dr. Gillies O’Bryan-Tear, chair of policy and communications for Britain’s Faculty of Pharmaceutical Medicine. It means the AstraZeneca one “may reach more parts of the world than the Pfizer one,” he said. Britain’s action likely means the World Health Organization will soon clear the AstraZeneca vaccine for use in a global effort to help poor countries, called COVAX. The initiative, led by WHO and the vaccines alliance GAVI, has secured access to at least 100 million doses of the vaccine, with options and other deals to buy more. But none can be distributed until green-lighted by WHO.
The U.N. health agency does not licence or regulate vaccines itself, but typically evaluates vaccines once they have been approved by an agency such as the U.K. regulator or the European Medicines Agency. WHO experts conduct their own evaluation of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation for the shots to be “pre-qualified” so they can be bought by donors for developing countries. Most coronavirus vaccines to be used in poorer countries likely will be made by the Serum Institute of India, which has been contracted by AstraZeneca to make 1 billion doses. In June, the pharmaceutical company announced that the Serum Institute would produce 400 million doses by the end of 2020 but as of early December, only about 50 million doses had been manufactured after production was halted several times. In addition to the Serum Institute, AstraZeneca also has deals with vaccine makers in Brazil, South Africa and China to make the Oxford-developed vaccine for use in developing countries.