As the global number of reported COVID deaths approaches three million, the news this week has been dominated by the US FDA and CDC pause of vaccinations with the Johnson & Johnson one shot vaccine. Vaccinations have also been paused in Europe and in other countries, including South Africa as pauses and restrictions continue in many countries around the AstraZeneca vaccine for similar reasons.
Even as many experts said the pause shows the vaccine safety system is working in the US, many are worried that the pause will increase vaccine hesitancy. And there is also concern that two vaccines—J&J and AstraZeneca—that have been seen as key for vaccine access in low- and middle-income countries may be seen as less desirable because of concerns resulting from the reports of blood clots among people who have received the vaccines.
Even as individuals, policy makers and health care workers grapple with the fallout from issues that have arisen around these two critical vaccines, less than 2.5 percent of the world’s population has been fully vaccinated.
If You Are in a Hurry
- Read Science on the emerging issues with adenovirus vector vaccines.
- Read an interview with science journalist Tara Haelle in Slate on why the J&J vaccine pause is science doing what it’s supposed to.
- Read about unique community-based programs to fight COVID vaccine hesitancy in the Miami Herald.
- Read Laura Lopez Gonzalez on prospects for an African-produced COVID vaccine in the Mail & Guardian.
- Watch this Nature video to understand more about variants.
- Read Apoorva Mandavilli on the epidemic of loss for women in science in the New York Times.
- Check out the touching photo “The Embrace that won the World Press Photo of the Year in The Week.
What Do We Need To Know About the J&J and Other Adenovirus Vaccines?
The Johns Hopkins International Vaccine Access Center (US) released a short document that outlines some key messages about the J&J pause. They note the adverse event of a certain kind of blood clot is “extremely rare…. The probability of experiencing this rare blood clotting side effect is less than one in a million…. We do know that the benefit of the vaccine—keeping people from being infected with the coronavirus or keeping those few who get COVID-19 out of the hospital—vastly outweighs the small risk of experiencing the blood clotting disorder.” Hopkins underscores that the FDA/CDC pause shows the system is working. “It is common for regulators to investigate ‘safety signals’ in medical products, including new vaccines. Very often, the signals prove not to be of concern. A vaccine safety signal is information that indicates that there could be a potential link between a vaccine and an event previously unknown or incompletely documented. The signal will suggest a new potentially causal association (or a new aspect of a known association) between a vaccine and an event….”
Science reports, “Researchers believe the problem, characterized by dangerous blood clots and low platelet counts, may be triggered by vaccines produced by AstraZeneca and Johnson & Johnson (J&J), which both contain a modified adenovirus. They have identified an errant immune reaction as the possible cause, but don't yet understand how it arises. There are 222 suspected cases of the syndrome so far in Europe among 34 million people who have received their first dose of the AstraZeneca vaccine, recently named Vaxzevria; more than 30 have died. The European Medicines Agency (EMA) on 7 April acknowledged “a probable causal association” between the syndrome and the vaccine, and some countries have restricted Vaxzevria to older age groups at higher risks of severe COVID-19…. So far, no similar cases have been reported in people who received Russia's Sputnik V or China's CanSino Biologics vaccine, which are both based on an adenovirus as well. But data on those vaccines have been limited, and it isn't clear that regulators in regions where they have been used would either pick up on or report such safety signals, says Peter Hotez, a virologist and vaccine expert at Baylor College of Medicine.”
Will the J&J Pause Increase or Decrease Vaccine Hesitancy?
Health and regulatory experts say the US pause of J&J vaccinations should decrease vaccine hesitancy – because it shows the safety system is working. But much of the media coverage and discussion of the pause expresses concern that it will increase hesitancy.
Reuters (UK) reports Fauci said, “that the pause should not prompt vaccine hesitancy. ‘It should reinforce in those individuals how we take safety so seriously.’"
Slate (US) headlines a conversation with a science journalist about the pause:
The J&J Vaccine Pause Is Science Working Like It’s Supposed To. Tara Haelle says, “A lot of people are like, ‘Why didn’t they catch this in the trials?’ Well, this is a one in a million event. You don’t have a million people in a clinical trial. You’re just not going to find a one in a million thing unless you’re testing millions of people.... Public health messaging has always been incredibly difficult, and we’ve been getting better at it, but we certainly have a long way to go. And part of the challenge is it’s two-pronged. One is that people don’t necessarily understand how science is an iterative process. It’s not a body of knowledge. It’s an ongoing, stumbling-toward-the-light process of identifying knowledge, which means that when things change, it doesn’t mean that facts change, it means new stuff has come to light. I was thinking of The Dude in
The Big Lebowski: ‘New shit has come to light.’ That’s the history of science right there.”
In a
MedPage Today (US) video conversation about the pause,
MedPage Today’s editor Marty Makary speaks to a hematologist about the blood clots and the pause. Makary notes, “Six cases of blood clots out of about seven million administrations, and one death. And they shut it down. I mean, help me understand. If they started doing that with all the medicines we use, we wouldn't have Tylenol. I mean, we wouldn't have 50 percent of the meds we have. Whatever happened to the benefit evaluation that a physician does and explaining risks to patients and letting them make a decision…. Totally shutting down a life-saving vaccine that, by the way, is more likely to access rural communities and lower-income populations because it doesn't require the freezer chain. And it's like, when you're weighing risks and benefits, to me the benefit is still there. I wouldn't recommend it for childbearing-age women because that's where we're seeing the complications. But it seems to me, we had a couple of hundred people die yesterday from COVID; there's one death out of seven million for the vaccine. To me, it seems like it's still worth having out there, but I wouldn't make that decision for anybody. I would give them the statistics.” The hematologist, Dr. Vinay Prasad, notes: “I do think you should have to factor in—after the pause, of course—you will have to factor in your age. You'll have to factor in your risk of SARS-CoV-2 bad complications, and you'll have to factor in the community spread of SARS-CoV-2 in your area…what might be best for an old frail person who is in a high prevalence county in Michigan right now, might be different than what's best for a young female living in California in a county that has very low transmission. And this is the kind of dialogue that we should've been having all along about the vaccine. It's also the dialogue that we will eventually have to have when it comes to vaccinating 12-year-olds and 13-year-olds and 14-year-olds. I think it's an important dialogue to have. What will they stand to gain...and what risks might still be uncertain.
Combatting Hesitancy at the Community Level
The
Miami Herald (US) reports on efforts to combat vaccine hesitancy among African American and Latino populations. “A new wave of public health advocacy that is multilingual, culturally sensitive, entertaining and personal is rapidly replacing mundane public service announcements on TV, radio and online in the battle to stamp out vaccine disinformation circulating in communities of color and get more people vaccinated.” These include: “In a Washington, DC, suburb, Black and Latino barbers are busting myths about the coronavirus vaccine while clipping hair. Across the country, a university researcher in Phoenix teamed up with a company behind comic books fighting Islamic extremism to produce dance-inducing animated stories in Spanish that aim to smash conspiracy theories hindering Latinos from getting inoculated. And in San Diego, former refugees, Latinos and Black activists initially hired by health officials as contact tracers are calling back the people they reached about COVID-19 exposure to talk about the shots.”
Thompson Reuters Foundation (UK) reports “Wariness about taking AstraZeneca's COVID-19 vaccine in Africa could be compounded by the African Union's decision to halt plans to procure the shot, health experts said on Friday, calling for public awareness programmes to fight misinformation…. Gregory Rockson, founder of Africa-wide healthcare provider mPharma, based in Ghana says, ‘We need strong political leadership and clear messaging to fight growing vaccine skepticism.’ More than 700 million vaccine doses have been administered globally, yet Africa accounts for less than 2 percent of the total compared to North America's 27 percent and Europe's 20 percent share, according to the latest data. In Malawi, where only about 1 percent of the population have been vaccinated, conspiracy theories about the AstraZeneca shot run rife, said Precious Makiyi, a medical doctor and behavioural scientist from Blantyre. ‘Now more than ever we need to understand why these theories exist and how we frame messaging targeted specifically at Malawians.’”
NPR (US) reports on efforts to ease vaccine hesitancy among African immigrants in the US. “In the United States, skepticism about the vaccine can be found in all segments of the population, including African Americans. However, efforts to address hesitancy among Black people often overlook African immigrants, who get much of their information from their countries of origin.” Dr. Frank Minja, originally from Tanzania says, “many African immigrants do not rely on American media as trusted sources of information. Some do not speak English well enough yet. Others are used to getting information from friends and family back home through social media platforms, such as WhatsApp.”
Vaccine Access
Reuters (UK) reports in a closed-door meeting WTO chief “Okonjo-Iweala said that concerns over cross-border supply chains, including export curbs and shortages of skilled personnel, had reinforced her view that the WTO must play a central role in the response to the pandemic…. WTO members, she said, needed to reduce export restrictions and work to ease logistics and customs procedures. They should also advance negotiations on a proposal by India and South Africa and backed by over 80 WTO members, to temporarily waive intellectual property (IP) rights of pharmaceutical companies.”
Truthout (US) reports, “Calling on US President Joe Biden to prioritize human need over corporate greed, more than 170 Nobel laureates and former heads of state and government on Wednesday sent an
open letter urging him to back a waiver of intellectual property rules so that developing nations can ramp up coronavirus vaccine production and pursue a people’s vaccine to help end a pandemic that has now
claimed nearly three million lives.”
The Star (Kenya) reports, “All teachers and support staff in schools, regardless of age, have been allowed to jump the queue and receive the COVID-19 vaccine” ahead of many schools reopening in early May.
The Herald (Zimbabwe) reports “Many people in African countries who have received their first shot of a COVID-19 vaccine do not know when they will get the second one due to delivery delays, according to the continent’s top public health official. ‘We cannot predict when the second doses will come and that is not good for our vaccination programme,’ John Nkengasong, the head of the Africa Centres for Disease Control and Prevention (Africa CDC), told reporters yesterday. Africa lags behind most other regions in COVID-19 vaccinations, with just under 14 million doses of mostly AstraZeneca vaccines having been administered on the continent of 1.3 billion.”
An African COVID Vaccine?
Laura Lopez Gonzalez reports in
Mail & Guardian (South Africa) that mRNA vaccine technology may be the key to African countries producing their own vaccines. “In the current COVID-19 pandemic, the power to produce a vaccine from its earliest stages still defines which countries have a vaccine and which nations will recover sooner…. More than a decade ago, African countries endorsed a
plan to increase their ability to make vaccines and other medicines. Still, only about 10 companies today do any type of vaccine manufacturing on the continent, and much of this has historically been confined to packaging formulated vaccines imported from abroad. But now, many on the continent—and abroad—are hoping that a relatively new vaccine technology could finally help African countries to take back control of their vaccines supplies—and their epidemics.”
Vaccine Misinformation
NPR (US) reports “The most popular link on Facebook about the Johnson & Johnson news was shared by a conspiracy theorist and self-described ‘news analyst & hip-hop artist’ named An0maly who thinks the pandemic is a cover for government control. It's a stark example of what experts warn could be a coming deluge of false or misleading information related to the one-shot vaccine.”
Breakthrough Infections, as Expected
The
Wall Street Journal (US) reports, “The US Centers for Disease Control and Prevention has identified a small cohort of approximately 5,800 cases of COVID-19 infection among more than 66 million Americans who have completed a full course of vaccination. These so-called breakthrough cases, which are defined as positive COVID-19 test results received at least two weeks after patients receive their final vaccine dose, represent 0.008 percent of
the fully vaccinated population. Officials said such cases are in line with expectations because the approved vaccines in the US are highly effective but not 100 percent foolproof. They are a reminder that even vaccinated people are at risk and should continue to take precautions such as masking and social distancing in many circumstances.”
Pancoronavirus Vaccines in the Future?
Jon Cohen reports in
Science, “In November 2020, [NIAID] solicited applications for ‘emergency awards”’ to pursue pancoronavirus vaccine development. And in March, the Coalition for Epidemic Preparedness Innovations (CEPI), an international nonprofit launched in 2017, announced it would spend up to $200 million on a new program to accelerate the creation of vaccines against beta coronaviruses, a family that now includes SARS-CoV-2…. The threat of another coronavirus pandemic now seems very real. Beyond bats, coronaviruses infect camels, birds, cats, horses, mink, pigs, rabbits, pangolins, and other animals from which they could jump into human populations with little to no immunity, as most researchers suspect SARS-CoV-2 did.” NIAID’s Barney Graham and others believe that a pancoronavirus vaccine might be the solution for SARS-CoV-2 variants as well. “If it can handle other members of the coronavirus family tree, it should have no problem dealing with variations of SARS-CoV-2, which are minor in comparison.”
P1 Variant Mutating More
Reuters (UK) reports, “Brazil's P1 coronavirus variant, behind a deadly COVID-19 surge in the Latin American country that has raised international alarm, is mutating in ways that could make it better able to evade antibodies, according to scientists studying the virus. Research conducted by the public health institute Fiocruz into the variants circulating in Brazil found mutations in the spike region of the virus that is used to enter and infect cells. Those changes, the scientists said, could make the virus more resistant to vaccines—which target the spike protein—with potentially grave implications for the severity of the outbreak in Latin America's most populous nation.”
To understand more about variants watch this
Nature video.
Challenge Trial
Bhekisisa (South Africa) reports, “The UK recently approved the world’s first COVID-19 human challenge trial which will expose up to 90 healthy people to the coronavirus in order to study how it affects our bodies…. As novel variants arise, some
experts say, future human challenge trials could hasten development of new vaccines and treatments for a disease that has killed more than 2-million people worldwide. But critics caution that there are ethical pitfalls to any research that intentionally sickens healthy people—and that even the best-planned trials may involve a small risk of serious complications.
Questions About Chinese Vaccine Efficacy
The
Washington Post reports “The head of the Chinese Center for Disease Control and Prevention conceded that the efficacy of Chinese coronavirus vaccines is ‘not high’ and that they may require improvements, marking a rare admission from a government that has staked its international credibility on its doses. The comments on Saturday from George Gao come after the government has already distributed
hundreds of millions of doses to other countries, even though the rollout has been dogged by questions over why Chinese pharmaceutical firms have not released detailed
clinical trial data about the vaccines’ efficacy.”
Antibody Injection Prevents COVID
STAT (US) reports Regeneron Pharmaceuticals said Monday that a single administration of its monoclonal antibody cocktail reduced the risk that volunteers exposed to COVID-19 would develop the disease by 81 percent. The study enrolled 1,500 healthy volunteers, each of whom shared a home with someone who tested positive for SARS-CoV-2, and randomized them to receive a single dose of its antibody treatment, given subcutaneously as four shots, or placebo. After 29 days, 11 patients in the treatment group developed COVID-19 compared to 59 on placebo. And for the subjects who got COVID-19 despite treatment, their symptoms resolved after one week, compared to three weeks for those on placebo.” Mike Cohen, lead investigator of the trial says this is “’a really, really big deal’…. He said that having to start an IV is ‘unequivocally’ one of the barriers to using the antibodies either for treatment or prevention. The other barrier? Awareness. ‘In order for these antibodies to be used for treatment and prevention and for treatment as prevention, we need the patients or their families familiar with the opportunity. We need health providers to be familiar with these drugs and comfortable administering them.’”
The Story of COVID Vaccines
Tony Fauci writes in
Science: “The speed and efficiency with which these highly efficacious vaccines were developed and their potential for saving millions of lives are due to an extraordinary multidisciplinary effort involving basic, preclinical, and clinical science that had been under way—out of the spotlight—for decades before the unfolding of the COVID-19 pandemic. When the stories and recounting of this pandemic are written, it is important that this history not be forgotten, as we are reminded once again of the societal value of a sustained and robust support of our scientific enterprise.”
Women in Science: An Epidemic of Loss?
Apoorva Mandavilli writes in
New York Times (US), “Several
studies have
found that
women have
published fewer papers, led
fewer clinical trials and received less
recognition for their expertise during the pandemic. Add to that the emotional upheaval and stress of the pandemic, the protests over structural racism, worry about children’s mental health and education, and the
lack of time to think or work, and an already unsustainable situation
becomes unbearable…. The path is even rockier for scientists of color… who encounter other biases in the workplace—in everyday reactions, professional reviews or promotions—and now have to cope with the disproportionate impact of the pandemic on Black and Latino communities…. A couple of years ago, Rockefeller University invited the news anchor Rachel Maddow to present a prestigious prize. On her way into the auditorium, Ms. Maddow pointed to a wall adorned with pictures of Lasker Award and Nobel Prize winners—all male—affiliated with the university. At least four women at the university had also won prestigious prizes, but their photographs were not on display. ‘What’s up with the dude wall?’ Ms. Maddow asked… Rockefeller University eventually agreed to replace the display with one that is more representative of the institution’s history.”
The Embrace
Remember hugs?
The Week (India) reports, “A photo symbolizing love and compassion of an 85-year-old Brazilian woman getting her first embrace in five months from a nurse through a transparent hug curtain was named the World Press Photo of the Year on Thursday. The choice of a winning photo portraying the global pandemic was almost inevitable for the contest covering a year in which news around the globe was dominated by the virus that has killed nearly 3 million people, including more than 360,000 in hard-hit Brazil.”
Pharma and COVID Scientists on TikTok
Fierce Pharma (US) reports, “TikTok, Twitter and social media in general are swelling with COVID-19 vaccine videos and posts. While that includes vaccination card selfies and vaccine encouragement videos, it also includes pharma brand shoutouts.”
Self-described “vaccine queen” and influencer Dr. Anna Blakney’s
Tiktok feed features vaccine information and big name scientists like Moderna co-founder
Bob Langer dancing.