The leading coronavirus vaccines are shaping up to be on par with some of the most effective vaccines in medicine, Axios’ Marisa Fernandez reports.
Why it matters:Vaccines with efficacy rates of about 95% — which both Pfizer and Moderna say they’ve achieved — will be more powerful weapons against the coronavirus than many experts had anticipated.
Flashback: The Food and Drug Administration initially set the bar for a COVID-19 vaccine at 50% efficacy, roughly in line with the seasonal flu vaccine.
Some scientists had hoped, in a best-case scenario, it might be as much as 70% effective.
“We don’t know yet what the efficacy might be. We don’t know if it will be 50% or 60%. I’d like it to be 75% or more,” the NIH’s Anthony Fauci said in August.
But coming in closer to 95% would put Pfizer and Moderna’s vaccines more in line with the highly effective inoculations against measles, mumps and rubella.
Like the MMR and polio vaccines, both prospective COVID-19 products would require two shots to reach that level of efficacy.
The third leading contender, being developed by AstraZeneca and Oxford University, would also require two shots. Johnson & Johnson is testing both a single-dose and a two-dose vaccine in simultaneous phase 3 trials.
Yes, but: There’s still a lot we don’t know about these vaccines, including how well they’re likely to work among various demographic groups, and how long the immunity they confer will last.
On Monday, Pfizer announced preliminary results from the phase 3 trial of the vaccine that it has developed with German company BioNTech, suggesting that it may be up to 90% effective at preventing Covid-19 with no serious safety concerns.The vaccine, which represents a new way to make a vaccine, might be ready for an Emergency Use Authorization from the FDA by the end of the year.
BioNTech’s vaccine is an mRNA (as in “messenger RNA,” which might ring a faint bell from high school biology class) vaccine, similar to one being developed by Boston-based Moderna as well as Translate Bio, which is partnered with pharmaceutical giant Sanofi. This type of vaccine has been in the works for other diseases, including the flu, but none have been approved for use by any regulatory body yet. Success with this platform has the potential to accelerate the development of vaccines for new diseases, a process which can typically take close to a decade.
Here’s what you need to know.
Pfizer’s vaccine is based on a new kind of technology
Traditional vaccines are made from dead or weakened versions of an infectious virus. This new type of vaccine is different. To develop it, the genes of the SARS-CoV-2 virus, which causes Covid-19, were first analyzed to locate the part that codes its “spike” protein, which is what enables the virus to infect people. The codes for that protein are then isolated and copied as mRNA fragments, which is what cells use as instructions for making proteins. Those fragments are packaged up into special molecules, then injected into the patient’s cells.
Within the cells, the mRNA comes into the body’s protein factories, called ribosomes. The ribosomes “read” the mRNA, and follow its instructions to make copies of the spike protein. Those copies of the spike protein can’t, by themselves, cause harm. But they’ll trigger the body to make antibodies against the virus. Those antibodies, in turn, will protect patients from a Covid-19 infection. At least, that’s the idea.
The vaccine still needs to be approved by the Food and Drug Administration
Before the vaccine can be distributed, it has to first be approved by appropriate regulatory bodies. In the United States, that’s the FDA. Pfizer has said that it intends to seek an Emergency Use Authorization from the FDA to enable distribution and administration of the vaccine in late November, at which point the company will have an average of two months’ worth of safety data for each patient. That’s because most bad reactions to vaccines happen shortly after infection. Additionally, Pfizer will continue to monitor the patients in its study for two years after the vaccine administration.
Distributing this vaccine is more complicated than for a typical vaccine
Although one advantage of mRNA vaccines is that they’re potentially faster to develop than traditional vaccines, their administration and distribution is scads more complicated. For example, the Pfizer vaccine is currently being tested on a two-dose schedule, 21 days apart, unlike the single dose of a typical vaccine for diseases like the flu. The 21-day separation has raised some concerns about the patient compliance needed for vaccines to work.
For long-term storage, the vaccine has to be kept at very cold temperatures—around –70° Celsius (–94° Fahrenheit), which requires a specialized freezer. (Flu vaccines, by contrast, can usually be stored in a refrigerator.) The company has developed a specialty thermal shipping container, which can be kept cold with dry ice and be used to store the vaccine doses for up to 15 days. If long-term storage isn’t required, Pfizer’s vaccine can be stored in a refrigerator, but only for up to five days.
Pfizer footed the bill for its own part of vaccine development
Several companies, such as Moderna, have received federal funding and support for the development of their vaccines and treatments through the research and development process. Pfizer opted out of that, choosing instead to spend $1 billion of its own money to move the vaccine forward. “A billion dollars is not going to break us,” CEO Albert Bourla told Forbes earlier this year.
President-elect Joe Biden and Vice President-elect Kamala Harris have released a seven-point plan regarding the COVID-19 pandemic.
The Biden administration’s seven pandemic plans:
1. Ensure all Americans have access to regular, reliable and free testing by doubling the number of drive-thru testing sites, investing in next-generation testing, developing a pandemic testing board to produce and distribute tests, and establishing a U.S. Public Health Jobs Corps.
2. Provide all states, cities, tribes and territories with critical supplies. Efforts will include full use of the Defense Production Act, building American-sourced and manufactured capabilities.
3. Provide clear, consistent and evidence-based guidance for how communities should navigate the pandemic. Planned resources will be tailored to the needs of schools, small businesses and families.
4. Plan for effective and equitable distribution of treatments and vaccines. The administration intends to invest in a $25 billion manufacturing and distribution plan to guarantee every American can receive the vaccine for free. The administration also said it will work to ensure that politics won’t play a role in determining the safety and efficacy of vaccines.
5. Protect older Americans and other high-risk groups. Efforts will include establishing a COVID-19 racial and ethnic disparities task force and a nationwide pandemic dashboard that can be checked in real-time to gauge local transmission.
6. Rebuild and expand defenses to prevent and mitigate pandemic threats, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense and the nation’s membership with the World Health Organization.
President-elect Joe Biden on Monday announced the members of his coronavirus task force, a group made up entirely of doctors and health experts,signaling his intent to seek a science-based approach to bring the raging pandemic under control.
Biden’s task force will have three co-chairs: Vivek H. Murthy, surgeon general during the Obama administration; David Kessler, Food and Drug Administration commissioner under Presidents George H.W. Bush and Bill Clinton; and Marcella Nunez-Smith, associate dean for health equity research at the Yale School of Medicine. Murthy and Kessler have briefed Biden for months on the pandemic.
Biden will inherit the worst crisis since the Great Depression, made more difficult by President Trump’s refusal to concede the election and commit to a peaceful transition of power. The Trump administration has not put forward national plans for testing, contact tracing and resolving shortages in personal protective equipment that hospitals and health-care facilities are experiencing again as the nation enters its third surge of the virus.
“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” Biden said in a statement. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”
The United States is recording more than 100,000 new coronavirus cases a day and, on many days, more than 1,000 deaths, a toll expected to worsen during the crucial 10-week stretch of the transition. It remains unclear whether Trump or his top aides will oversee and lead a robust response to the pandemic during the transition, which could further exacerbate the crisis Biden and Vice President-elect Kamala D. Harris inherit.
The 13-member task force also includes former Trump administration officials, including Rick Bright, former head of the Biomedical Advanced Research and Development Authority, who, after being demoted, spoke out against the administration’s approach to the pandemic. Luciana Borio, director for medical and biodefense preparedness on Trump’s National Security Council until 2019, is also on the panel.
The group includes several other prominent doctors:
· Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.
· Atul Gawande, a surgeon at Brigham and Women’s Hospital and a professor at Harvard Medical School who is a prolific author.
· Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
· Eric Goosby, global AIDS coordinator under President Barack Obama and professor of medicine at the University of California at San Francisco School of Medicine.
· Celine R. Gounder, clinical assistant professor of medicine and infectious diseases at New York University’s Grossman School of Medicine.
· Julie Morita, executive vice president of the Robert Wood Johnson Foundation, a philanthropy focused on health issues.
· Loyce Pace, president and executive director of the Global Health Council, a U.S.-based nonprofit organization dedicated to global health issues.
· Robert Rodriguez, professor of emergency medicine at the UCSF School of Medicine.
Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University Medical Center, and Beth Cameron, director for global health security and biodefense on the White House National Security Council during the Obama administration, are serving as advisers to the transition task force.
Task force members will work with state and local officials to craft public health and economic policies to address the virus and racial and ethnic disparities, while also working to reopen schools and businesses, the transition team said in a news release.
While the makeup of the task force garnered widespread praise, Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, said the group needs more geographic diversity.
“They are all from the Acela corridor or the [San Francisco] Bay Area,” he said. “Who is going to be the field marshal or the supreme allied commander who goes into middle of the country and get this done? The coasts are doing okay but the red states are being hammered and the deaths are going to be extraordinary. There needs to be a frank reckoning between leaders of the two parties, to say we cannot let this happen.”
Public health experts said Biden should use the transition to provide leadership as the pandemic continues through a deadly stretch and begin communicating a strong national message.
“Clearly from the election outcomes, half the country doesn’t believe we’re in a crisis,” said Kavita Patel, a fellow at the Brookings Institution who worked on health policy in the Obama administration. Biden and Harris “have an incredible platform that can be used for communication. The country needs clear daily briefings that we thought we’d get from the White House coronavirus task force. They have an incredible platform, if not an official platform.”
Biden plans to call Republican and Democratic governors to ask for their help in developing a consistent message from federal and state leaders, according to three Biden advisers who spoke on the condition of anonymity because they were not authorized to speak publicly about these matters. He will urge governors to adopt statewide mask mandates and to provide clear public health guidance to their constituents, including about social distancing and limiting large gatherings.
The task force will have subgroups that focus on issues related to the response, including testing, vaccine distribution and personal protective equipment, according to two people familiar with the plans who spoke on the condition of anonymity to reveal plans that were not yet public.
In his victory speech Saturday, Biden addressed challenges in bringing the pandemic under control.
“We cannot repair the economy, restore our vitality or relish life’s most precious moments — hugging a grandchild, birthdays, weddings, graduations, all the moments that matter most to us — until we get this virus under control,” Biden said. “That plan will be built on a bedrock of science. It will be constructed out of compassion, empathy and concern. I will spare no effort — or commitment — to turn this pandemic around.”
Yet the plans Biden laid out on the campaign trail are set to collide with political realities. That includes a deeply divided nation in which more than 71 million people voted for Trump and the possibility of having to navigate a Republican-controlled Senate disinclined to support a greater federal role in testing and contact tracing, among other responsibilities now left mostly to the states.
Biden’s most ambitious plans will require significant congressional funding. Senate Majority Leader Mitch McConnell (R-Ky.) has said he would like to pass new coronavirus relief measures during Congress’s lame-duck session, and Congress faces a Dec. 11 government funding deadline. Biden and his team are poised to begin engaging with congressional Democrats on their priorities.
Biden’s plans include dramatically expanding testing and building a U.S. public health jobs corps to have 100,000 Americans conduct contact tracing. They also include ramping up production of personal protective equipment and implementing a vaccine distribution plan.
Murthy, who served as the 19th U.S. surgeon general, is a physician whose nomination was stalled in the Senate for more than a year because of his view that gun violence is a public health issue. Three months into the Trump administration, he was replaced as “the nation’s doctor” with more than two years left on his four-year term.
In 2016, he wrote a landmark report on drug and alcohol addiction, which put that condition alongside smoking, AIDS and other public health crises that previous surgeons general addressed. The report called the addiction epidemic “a moral test for America.” Murthy’s office sent millions of letters to doctors asking for their help to combat the opioid crisis.
The son of immigrants from India, he earned medical and MBA degrees at Yale before joining the faculty at Harvard Medical School, where his research focused on vaccine development and the participation of women and minorities in clinical trials.
After leaving his post as surgeon general, he wrote a book on loneliness and social isolation, including their implications for health, that grew out of his conversations with people in clinical practice and as surgeon general.
Several public health officials celebrated Nunez-Smith’s leadership role on the task force. Her research focuses on promoting health and health-care equity in marginalized populations, according to her Yale biography. She has also studied discrimination that patients endure in the health-care system — expertise that many said was welcome in an epidemic that is disproportionately affecting people of color.
Kessler was FDA commissioner from 1990 to 1997, during the George H.W Bush and Clinton administrations. He is well-known for his attempts to regulate cigarettes — an effort that resulted in a loss in the Supreme Court, which ruled that the agency did not have the authority. That prompted Congress to pass a law, enacted in 2009, that explicitly gave the agency that power.
Kessler, a pediatrician and lawyer, worked at the FDA to accelerate AIDS treatments and on food and nutrition issues. He oversaw the FDA’s development of standardized nutrition labels and notably ordered the seizure of orange juice labeled “fresh” because it was made from concentrate. He has written several books on diet, mental illness and other topics, and has served as dean of the medical schools at Yale and UCSF.
A promising vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech would need to be stored at ultracold temperatures that experts say could make it far more difficult to distribute than other potential vaccines.
Pfizer announced Monday that an interim analysis had shown the vaccine was more than 90 percent effective, news that was greeted with near universal celebration among experts.
But the Pfizer vaccine is relatively unusual as it has to be stored and transported at an ultracold temperature of around -94 Fahrenheit (-70 Celsius), significantly complicating the process of getting the vaccine to people.
Ultracold storage is “is not necessarily routinely available in most health centers even in the U.K., let alone globally,” Michael Head, a fellow in global health at the University of Southampton said in a statement.
Vaccines often require some kind of cold storage to remain effective; some candidates for a coronavirus vaccine need to be held at cooler temperatures like 26 Fahrenheit (2 Celsius). They need to be kept this temperature not only while in storage but also while being delivering on planes and trucks.
The Pfizer vaccine would be considerably colder, requiring more than just refrigeration but something capable of producing freezing temperatures even during potential lengthy periods of transport. It has been done before, though at a smaller scale: A vaccine for the Ebola virus was notable for requiring ultracold storage. Pfizer has been preparing for the challenge by creating special containers that can last 10 days at -94 Fahrenheit, according to the Wall Street Journal.
Groups like the World Health Organization and UNICEF have said that countries need to improve their “cold chain” logistical networks to make sure vaccines can be distributed safely.The Associated Press reported last month that nearly 3 billion people live in areas where temperature-controlled storage is insufficient for the task.
The United States surpassed 10 million coronavirus cases on Monday, just 10 days after hitting 9 million. The average number of daily new infections has exceeded 100,000, and public health experts warn the country is entering the pandemic’s worst phase yet.
The upcoming election has huge implications for healthcare, far beyond how COVID is managed, ranging from how care is covered to how it’s delivered. The graphic above shows a continuum of potential policy outcomes of the November 3rd vote.
If President Trump wins a second termand Republicans control at least one house of Congress, there will likely be more attempts to dismantle the ACA, as well as continued privatization of Medicare coverage.
If Democrats win the presidency and sweep Congress, actions to expand the Affordable Care Act (ACA), or even create a national public option, are on the table—although major healthcare reform seems unlikely to occur until the second half of a Biden term.
In the short term, we’d expect to see more policy activity in areas of bipartisan agreement, like improving price transparency, ending surprise billing and lowering the cost of prescription drugs, regardless of who lands in the White House.
While healthcare emerged as the most important issue for voters in the 2018 midterm elections, the COVID pandemic has overshadowed the broader healthcare reform platforms of both Presidential candidates heading into the election. As shown in the gray box, many Americans view the election as a referendum on the Trump administration’s COVID response. Managing the pandemic is one of the most important issues for voters, especially Democrats, who now rank the issue above reducing the cost of healthcare or lowering the cost of drugs.
In many aspects, the COVID policies of Biden and Trump are almost diametrically opposed, especially concerning the role of the federal government in organizing the nation’s pandemic response.
The next administration’s actions to prevent future COVID-19 surges, ensure safe a return to work and school, accelerate therapies, and coordinate vaccine delivery will remain the most important aspect of healthcare policy well into 2021.
Anthony Fauci, MD, says talk about a second wave of the coronavirus is premature because the United States is still dealing with the first one.
The idea of a second wave is based on the 1918 flu pandemic, when many cases were seen in the spring, he says. The spring cases “literally disappeared” and were followed by a spike in flu cases in the fall, he told CNN’s Sanjay Gupta, MD, on Thursday in an online conversation organized by Emory University.
“Rather than say, ‘A second wave,’ why don’t we say, ‘Are we prepared for the challenge of the fall and the winter?’” said Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force.
Flu shots are an important measure to help the U.S. get through the winter, he said.
He and other health care professionals have observed that the Southern Hemisphere has had a very light flu season, probably because measures to curb the coronavirus, such as social distancing and mask-wearing, have limited the spread of the flu.
“If we listen to the public health measures, not only would we diminish the effect of COVID-19, we might get away with a very, very light flu season if we combine that with getting the flu vaccine,” Fauci said.
In a separate interview, he said the arrival of the coronavirus vaccine will not stop the need for tried-and-true measures such as mask-wearing, hand-washing, and social distancing.
In a Facebook Live conversation with New Jersey Gov. Phil Murphy, Fauci said the coronavirus vaccine will not be 100% effective and won’t be taken by the entire population. That means the virus could still spread.
“So when a vaccine comes, we look at it as an important tool to supplement the public health measures that we do,” he said. “It will allow us to more quickly and with less stringency get back to some degree of normal. But it is not going to eliminate the need to be prudent and careful with our public health measures.”
Fauci said that vaccinating 75% to 80% of the population “would be a really good accomplishment.” He expects 700 million doses to be produced by the end of this year or early 2021.
Medicare won’t cover the cost of a COVID-19 vaccine if it is approved under an emergency use authorization, according to The Wall Street Journal.
The White House recently concluded that Medicare’s exclusion of emergency-use drug costs could mean 44 million Americans, or 15 percent of the U.S. population, may have to pay out-of-pocket for a vaccine if it is approved under an emergency use authorization, the Journal reported.
HHS is now exploring coverage options, and a spokesperson told the Journal any vaccine doses bought by the government will be provided free.
The administration of President Donald Trump has pushed for a COVID-19 vaccine to be approved and distributed before the presidential election, which would likely only come with an emergency use authorization, since FDA approvals take more time.
In March, lawmakers passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which ensures no out-of-pocket costs for COVID-19 vaccines for people on Medicare.
HHS also said in August that government health insurance programs, including Medicare and Medicaid, would cover the costs of administering a COVID-19 vaccine.
Optimism that vaccines are on the way to end the coronavirus pandemic has been a major factor in this year’s U.S. stock resurgence. That will face a critical test in coming weeks, as investors await clinical data on whether they actually work.
A UBS analysis found that about 40% of the market’s gains since May can be pegged to hopes for vaccines to protect against COVID-19, which has killed over 960,000 worldwide and rocked the global economy.
Global efforts to develop a vaccine are coming to a head, with late-stage data on trials by companies such as Pfizer Inc <PFE.N> and Moderna Inc <MRNA.O> possible as soon as October or November. Disappointing results could further shake markets that have recently grown turbulent on worries over fiscal stimulus delays and uncertainty around the Nov. 3 U.S. presidential election.
“The anticipation is that this stuff is going to work,” said Walter Todd, chief investment officer at Greenwood Capital in South Carolina. “So any news to the contrary could be a risk to the market.”
The number of vaccines in development could blunt the negative market impact of any single setback. More than a half-dozen vaccines globally are in late-stage trials out of over 30 currently being tested in humans, according to the World Health Organization.
“We are setting ourselves up for success in the sense of if you throw enough spaghetti at the wall, hopefully at least one noodle sticks,” said Liz Young, director of market strategy at BNY Mellon Investment Management.
That could explain why stocks overall barely reacted earlier this month, when AstraZeneca Plc <AZN.L> and partner Oxford University paused global trials of one of the leading vaccine candidates after a participant in its U.K. trial became seriously ill. The trials have resumed in Britain, Brazil and South Africa, but remain on hold in the United States.
Some forecasts on vaccine availability have grown less optimistic. Good Judgment, a company whose forecasters make predictions based on publicly available evidence, put the chances that a vaccine will be widely distributed in the United States by the end of March at 54%. That is up from an estimate of less than 20% in early July, but down from above 70% earlier this month.
Pfizer and Moderna could report initial efficacy results in October or November based on an early read of data, followed by data from companies such as AstraZeneca, Johnson & Johnson <JNJ.N> and Novavax Inc <NVAX.O>.
An approval or emergency use authorization this year could lead to a surge in travel, leisure and other stocks that have been decimated by pandemic-related shutdowns, while also fueling a long-awaited shift into value stocks from tech and other growth names that have led the market for years.
Even if a vaccine is approved, questions persist about how easily and quickly it can be distributed. President Trump and his health officials have issued conflicting predictions about when the general public could have access.
“The potential for market disappointment will likely come from the realization that manufacturing and broad distribution will take longer,” said Art Hogan, chief market strategist at National Securities.
An approved, broadly distributed and accepted vaccine could result in a gain of about 300 points to the S&P 500, or more than 8% at the index’s current level, according to Keith Parker, head of U.S. and global equity strategy at UBS.
If a vaccine is widely distributed in the first quarter, BofA Global Research projects global gross domestic product (GDP) growth of 6.3% in 2021, compared with 5.6% if that does not occur until the third quarter.
Disappointing clinical trial news could result in a loss of 100 points from the S&P 500, or about 3%, Parker estimates.
While the market might be able to handle one vaccine setback “reasonably well,” several setbacks could cause a rethink of the vaccine race, he said.