The European Union has agreed to return millions of COVID vaccines doses partially produced in South Africa back to the African continent.
South Africa’s Aspen Pharmacare operates the plant that is partially producing Johnson & Johnson vaccines, where vaccine substance from Europe is sent to be bottled and shipped.
The plant is supposed to produce 400 million doses for the AU’s African Vaccine Acquisition Trust through 2022, to be purchased by African nations using World Bank financing. Shipments started in August, with 6.4 million doses delivered to countries, but they have been limited due to the manufacturing plant’s production capacity.
The announcement came as Africa struggles to immunise its population against COVID, partly due to a lack of supply resulting from wealthier countries buying up most vaccines, and also from widespread vaccine hesitancy.
“All the vaccines produced at Aspen will stay in Africa and be distributed to Africa,” said Strive Masiyiwa, special African Union envoy. “This issue has been corrected and corrected in a very positive way.”
The announcement came after a meeting in Berlin between South African President Cyril Ramaphosa and European Commission President Ursula Von der Leyen, he said, adding that the first supplies were expected this month.
“In addition, the Europeans committed to give us 200 million doses before the end of December,” Masiyiwa said at the briefing by the Africa Centres for Disease Control and Prevention.
About 2.93% of people who have been fully immunised against COVID, said Africa CDC director John Nkengasong. The World Health Organization meanwhile warned that eight out of 10 African countries were likely to fall short of the “crucial” goal of vaccinating the most vulnerable 10% of their populations against COVID by the end of the month.
On Monday, the US Food and Drug administration approved the Pfizer/BioNTech COVID vaccine, the first vaccine against the novel coronavirus to receive full approval.
The vaccine, which will be marketed as Comirnaty, can be used for individuals ages 16 and older for COVID prevention. However, the vaccine is still under emergency use authorisation (EUA) for adolescents ages 12-15, the agency said.
FDA Acting Commissioner, Janet Woodcock, MD, said in a statement: “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved COVID vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
At a media briefing, Peter Marks, MD, PhD, the director for the Center for Biologics Evaluation and Research at FDA, detailed the meticulous process used for conducting a review of a biologics license application for full approval, including invidivual analysis of adverse events.
Since 11 December, 2020, the vaccine has been under an EUA for individuals ages 16 and older. Evidence for the full approval comes from expanded phase III trial safety and efficacy data released by the manufacturer this April. An analysis of 927 confirmed cases in the trial’s 44 000 participants found that 7 days after the second dose, Comirnaty had a 91.3% efficacy against symptomatic COVID through 6 months.
More than half of the participants had over 4 months of safety data, including 12 000 people who were followed up through 6 months. Injection site pain, fatigue, headache, muscle or joint pain, and fever were the most common adverse events. A slight increase in risk for myocarditis and pericarditis up to 7 days after the second dose was noted, particularly in males under 40 (peaking in ages 12-17), but symptoms resolved completely.
Trial data was collected before the Delta variant became the dominant strain in the US, Dr Marks noted, Israeli “real world” suggest the vaccine still retains effectiveness but wanes. This is something the agency will follow.
Former FDA commissioner Dr. Mark McClellan, who now directs the Duke-Margolis Center for Health Policy, spoke to the media about the approval, saying surveys showed that it will help sway vaccine holdouts.
“I do think it will make a difference. Maybe not a large number of people running out and getting a vaccine today. At this point we’ve got a little bit over 70 percent of Americans who are eligible for the vaccine have gotten at least one dose. That’s about 87 million Americans who are eligible who haven’t. Out of those, according to some recent surveys, about 30 percent say the full approval of the Pfizer vaccine would make a difference in their decisions.”
A UK study has furthered the understanding of the novel blood-clotting condition associated with the Oxford/AstraZeneca vaccine.
Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is characterised by a blockage of veins and a marked platelet reduction. The rare condition was first identified in the UK by Professor Marie Scully (University College of London Institute of Cardiovascular Science), also a Consultant Haematologist at UCLH, and Dr Will Lester from University Hospitals Birmingham NHS Foundation Trust.
The cases were presented by 182 consultant haematologists, and builds on understanding about the condition outlined in an April 2021 NEJMpaper led by Professor Scully.
Meanwhile, a study led by Dr Richard Perry (UCL Queen Square Institute of Neurology and UCLH) published in the Lancetearlier this month provided the most detailed observations so far of cases of cerebral venous thrombosis (CVT). one of the commonest and severest manifestations of VITT.
The overall mortality rate of those presenting to hospitals with definite or probable VITT was 23%, the paper reported. The condition almost entirely manifested between five and 30 days after their first vaccination, with no sex differences seen, and no predisposing prior medical conditions.
The chances of death increased significantly the lower the platelet count and the greater the activation of the blood clotting system, increasing to 73% in patients with a very low platelet count and intracranial haemorrhage following blood clots in the brain.
Overall, 41% of patients had no previous medical diagnoses and 85% were less than 60 years old. Overall incidence in individuals under 50 was estimated to be 1 in 50 000 – in line with reports from other countries.
Though optimal treatment was still uncertain, it was being continually refined in real time, the researchers wrote. For instance, the introduction of the use of plasma exchange in the most severe cases has led to survival rates that were significantly better than would be predicted based on baseline characteristics.
The research adds to evidence for use of non-heparin-based blood thinners to tackle blood clotting in cases of VITT, and that use of intravenous immunoglobin was associated with better outcomes.
Professor Scully said: “As a new condition we are still learning about how best to diagnose and manage VITT, but as time goes on, we have been able to refine our treatment approaches and improve rates of survival and chance of recovery. This continuous learning in real time has been made possible thanks to collaboration between colleagues across the UK.”
Lead author Dr Sue Pavord, at Oxford University Hospitals NHS Foundation Trust, said: “We have worked relentlessly to understand and manage this new condition, so that the hugely successful vaccine roll out can continue, which is the most viable solution to the global pandemic.”
Johnson & Johnson’s COVID vaccine is much less effective against the Delta and Lambda variants than against the original wild-type virus, according to a new study posted on the BioRxiv preprint server on Tuesday.
Though a cause for concern, the results come from in vitro tests, and may not reflect the real world vaccine performance. However, the authors said this adds to evidence that the 13 million people inoculated with the J&J vaccine may need a second dose, preferably an mRNA vaccine, the authors said. The findings, which are still to be peer reviewed, are however consistent with observations that a single dose of the AstraZeneca vaccine, which is similar to the J&J one, shows only about 33 percent efficacy against developing symptoms with the Delta variant.
“The message that we wanted to give was not that people shouldn’t get the J&J vaccine, but we hope that in the future, it will be boosted with either another dose of J&J or a boost with Pfizer or Moderna,” said study leader Nathaniel Landau, a virologist at NYU’s Grossman School of Medicine.
Other experts said the results are what they would have expected, because all of the vaccines seem to work better when given in two doses. “I have always thought, and often said, that the J&J vaccine is a two-dose vaccine,” said John Moore, a virologist at Weill Cornell Medicine in New York.
Dr Moore pointed to several studies in monkeys and people that have shown greater efficacy with two doses of the J&J vaccine, compared with one dose. The new study was particularly credible, he said, because it was published by a team not linked to any vaccine manufacturer.
But the data from the new study “do not speak to the full nature of immune protection,” said Seema Kumar, a spokeswoman for J&J. “Studies sponsored by the company indicate that the vaccine “generated strong, persistent activity against the rapidly spreading Delta variant,” she said.
The Delta variant is the most transmissible of the SARS-CoV-2 variants, and has become dominant in South Africa.
Several studies have suggested that the mRNA vaccines made by Pfizer-BioNTech and Moderna will maintain their efficacy against the coronavirus, including all variants identified so far. One recent study showed, for example, that the vaccines trigger a persistent immune reaction in the body that may protect against the coronavirus for years. The J&J vaccine is newer, and has had fewer studies.
The J&J vaccine has had reports of rare blood clots and extremely rare neurological disorders, as well as problems with contamination at a US manufacturing plant. This is still not as bad as the disastrous news that the AstraZeneca vaccine was virtually ineffective against the Beta variant which was then the dominant strain in South Africa.
Small studies by J&J affiliated researchers suggested that the vaccine was only slightly less effective against the Delta variant than against the wild-type virus, and that antibodies stimulated by the vaccine grew in strength over eight months.
Dr Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston said it was important to consider the vaccine’s strength over time.
“Fundamentally I don’t see that there’s any discordance,” he said. “The question is that of kinetics, it’s not just magnitude, because immune responses are not static over time.” The new study also did not consider other components of immune defence, he added.
Dr Landau and his colleagues had compared blood samples taken from 17 people who had two doses of an mRNA vaccine and 10 who had one J&J vaccine dose.
The J&J vaccine started out with a lower efficacy than the mRNA vaccines and showed a bigger drop in efficacy against the Delta and Lambda variants. “The lower baseline means that what’s left to counter Delta is very weak,” Dr Moore said. “That is a substantial concern.”
Very few vaccines are given as a single dose, because the second dose is needed to amp up antibody levels, noted Akiko Iwasaki, an immunologist at Yale University. People who were inoculated with the J&J vaccine “are relying on that primary response to maintain high levels of antibodies, which is difficult, especially against the variants,” she said.
Boosting immunity with a second dose should raise the antibody levels high enough to counter the variants, she said.
The case of a patient who experienced two facial palsies, both immediately after receiving the Pfizer-BioNTech vaccine, strongly suggests that they are linked to the vaccine, wrote in the journal BMJ Case Reports.
The case report of two separate unilateral facial nerve palsies, where muscles on one side of the face become weak or paralysed, occurring shortly after each dose of a COVID vaccine, is the first in medical literature.
“The occurrence of the episodes immediately after each vaccine dose strongly suggests that the Bell’s palsy was attributed to the Pfizer-BioNTech vaccine, although a causal relationship cannot be established,” the authors said.
Single episodes of unilateral facial nerve palsies were reported in the initial clinical trials of Pfizer-BioNTech, Moderna and Oxford/Astra Zeneca and there have been subsequent case reports.
In phase 3 trials, four cases of facial palsy of unknown cause (Bell’s palsy) were reported in volunteers who received the Pfizer-BioNTech mRNA vaccine and none in the placebo group, and three cases were reported in volunteers who received the Moderna mRNA vaccine compared with one in the placebo group. Three cases of facial nerve palsy were also reported in volunteers who received the Oxford/AstraZeneca vaccine, and there were three cases in the placebo group.
This case report describes a 61-year-old Caucasian male with no previous history of facial nerve palsy who experienced an episode of Bell’s palsy on the right side of his face five hours after receiving his first dose of the Pfizer-BioNTech vaccine, and a more severe episode of Bell’s palsy on the left side of his face two days after receiving the second dose. The patient had a high BMI, hypertension, hypercholesterolaemia and type 2 diabetes.
After the first episode, the patient went to the emergency department, with incomplete eye closure and no forehead movement and was diagnosed with Bell’s palsy. Blood tests and a CT head scan revealed no pathologies and he was discharged with a course of steroids, and the right-sided facial nerve palsy completely resolved.
Two days after his second shot, he developed a more severe left-sided facial nerve palsy. The symptoms included dribbling, difficulty swallowing and again, incomplete left eye closure. He went to the emergency department, where he was again prescribed a course of steroids. He was also referred to an emergency Ear Nose and Throat clinic, which continued the steroids and referred him to ophthalmology.
The authors reported that the patient is almost back to normal. “The patient has been advised to discuss future mRNA vaccines with the GP on a case-by-case basis, taking into account risk versus benefit of having each vaccine,” they said.
Bell’s palsyis believed to be related to facial nerve inflammation and oedema from viral infection. In 2004 the inactivated intranasal influenza vaccine was shown to significantly increase the risk of Bell’s palsy and was discontinued. Increased incidence of Bell’s palsy has also been seen following administration of other influenza and meningococcal vaccines. The annual incidence is 15 to 20 per 100 000 and the lifetime risk is 1 in 60, with an 8% to 12% recurrence rate.
While most cases of Bell’s palsy recover on their own over time, the symptoms can cause significant temporary disability, affecting facial expression and eating and drinking. Risk factors for the condition include diabetes, obesity, hypertension, pregnancy, pre-eclampsia and upper respiratory disease.
Immunotherapy company ImmunityBio has been authorised by the South Africa Health Products Regulatory Authority (SAHPRA) to proceed with the South Africa Sisonke T-Cell Universal Boost trial.
The Phase 1/2/3 study, starting in the second third quarter of 2021, is designed to evaluate hAd5 Spike + Nucleocapsid (S+N) as a boost for South African healthcare workers previously vaccinated with an S (Spike)-only vaccine.
“With the virus continuing to spread, moving forward with this boost trial is crucial,” said Leonard Sender, MD, Chief Operating Officer of ImmunityBio. “We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response—equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus.”
In the trial, the effect of combining vaccination by subcutaneous (SC) and sublingual (SL) routes will be assessed. This combination has the potential to deliver protection from the virus with a single injection followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant’s needs or situation. Sublingual administration offers the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-injection formulations do not need a trained healthcare worker to administer them and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.
“The number of new cases in South Africa is frightening, particularly when you consider recent data suggesting currently available COVID-19 vaccines may not provide the immune memory needed to fend off infection from future variants. This highlights an urgent need for a boost dose that confers long-term protection by activating both antibodies and T cells, ” said Patrick Soon-Shiong, MD, Founder and Executive Chairman of ImmunityBio.
“Several peer-reviewed studies demonstrate that patients who have recovered from SARS-CoV in the 2003 outbreak possess long lasting memory T cells reactive to the nucleocapsid protein of SARS-CoV 17 years after infection. While antibodies block infection when present, T cells are vital for long-term immune memory. We are excited to begin this controlled, randomized trial of boosting a previously administered DNA-based viral vector vaccine with our own Ad5 dual-antigen S plus N vaccine to see if it can augment protection in participants who have received the S-based vaccine alone,” added Dr Soon-Shiong.
South Africa is planning to make vaccines locally using messenger RNA, the breakthrough technology of the global COVID vaccination effort – and once nearly consigned to the dustbin of medical research history.
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub.
This follows WHO’s global call for Expression of Interest to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. The partners will negotiate details with the South African government and public and private partners both local and international.
South African President Cyril Ramaphosa said: “The COVID pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.”
“This is great news, particularly for Africa, which has the least access to vaccines,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “COVID has highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.”
The announcement follows the recent visit to South Africa by French President Emmanuel Macron, who gave his country’s commitment to aiding local vaccine production.
“Today is a great day for Africa. It is also a great day for all those who work towards a more equitable access to health products. I am proud for Biovac and our South African partners to have been selected by WHO, as France has been supporting them for years,” said President Macron. “This initiative is the first of a long list to come, that we will keep supporting, with our partners, united in the belief that acting for global public goods is the fight of the century and that it cannot wait.”
Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed. Interested manufacturers from low- and middle-income countries can receive training and any necessary licences to the technology, assisted by the WHO and partners.
Biovac is a bio-pharmaceutical company resulting from a partnership formed with the South African government in 2003 to establish local vaccine manufacturing capability for the provision of vaccines for national health management and security.
Afrigen Biologics and Vaccines is a biotechnology company focuses on product development, bulk adjuvant manufacturing and supply and distribution of key biologicals to address unmet healthcare needs.
The organisations complement one another, and can each take on different roles within the proposed collaboration: Biovac will be the developer while Afrigen is the manufacturer, with a consortium of universities as academic supporters providing mRNA know-how. Africa CDC will provide technical and regional support.
The South African consortium has existing operating facilities with available capacity and experience in technology transfers. It is also a global hub that can start training technology recipients immediately.
The WHO is speaking to a number of pharmaceutical manufacturers about establishing the hub, though the talks are so far mainly with “smaller companies,” said Soumya Swaminathan, WHO’s chief scientist. “We are having discussions with the larger companies with proven mRNA technology,” she added.
The mRNA vaccines may be produced in South Africa within 9 to 12 months, she said. WHO’s call for expressions of interest has so far generated 28 offers to either provide technology for mRNA vaccines or to host a technology hub or both.
It is the first time that messenger RNA technology has been used to make vaccines, which has been used by Moderna and Pfizer/BioNTech. They have proven very effective against the original SARS-CoV-2 strains and even against its more recent variants.
The Phase I clinical trial of ImmunityBio’s experimental COVID vaccine, designed to be effective against COVID variants, is about to be expanded to include different administration routes as well as effectiveness in people who previously had COVID.
Co-investigator Prof Graeme Meintjes, second chair in the Department of Medicine at UCT, said that the Phase I trial has started and is still ongoing at the Wellcome Centre for Infectious Diseases Research in Africa’s (CIDRI-Africa) Khayelitsha clinical research site.
He said that the first two cohorts of ten participants each both received two subcutaneous injections of the vaccine, three weeks apart, with one cohort receiving a higher dose.
“The purpose of that was to assess safety, so participants were followed up very carefully for side effects and for reactions to the vaccine. And the review of that suggests no major safety concerns,” he explained. He added that the Phase I trial design has since been adapted to include four more cohorts, which is going through the approval process. These four additional cohorts will include people who have had COVID because the researchers want to look at the effect the vaccine will have on boosting existing immunity against COVID. Each cohort will have ten participants, bringing the expected total number of participants for Phase I to 60 people.
New administration routes
To see whether different administration routes produce a sufficient immune response, each participant in these new cohorts will receive one dose of the vaccine through one of four routes. These would be either a subcutaneous injection, a sublingual route, a combination of subcutaneous injection and sublingual method, or an intranasal route.
“We’ll be measuring the antibody responses as well as the T-cell responses to the vaccine, but we do not have results yet,” said Meintjes. He added that enrolment should be complete in the next two months, pending the outcome of the approval process.
Phase II/III trial plans
Phase II and Phase III trials in South Africa are being planned, which will be headed by the South African Medical Research Council (SAMRC), Mentjes confirmed.
Details will be made available once the trial has been approved by SAHPRA. It is unlikely that placebos will be used, now that vaccines are shown to be effective; rather different vaccines will be compared.
Broader immune response with two-pronged defence
The vaccine has been designed to potentially offer a broader, long-lasting immune response, Mentjes noted. In this way it should also provide improved protection against COVID variants.
Currently, most of the COVID vaccines are designed to produce an immune response against the spike protein of the virus, but it mutates rapidly, allowing certain variants to partially or fully escape vaccines.
The ImmunityBio vaccine aims to offer a two-pronged or dual defence, Meintjes said, with the vaccine containing two proteins from the SARS-CoV-2 virus: the spike protein along with the more stable nucleocapsid protein. The nucleocapsid is an RNA-binding protein which is critical for viral replication and genome packaging.
He explains that targeting nucleocapsid could potentially provide more durable and long-term protection against different variants of the SARS-CoV-2 virus because the immune system will recognise the nucleocapsid even when the spike protein changes.
“The hope is that by including the nucleocapsid you would generate a vaccine response that covers emerging variants, those that have emerged and those that might emerge in the future,” he says.
Human-adenovirus based vaccine carrier
The ImmunityBio vaccine will use an adenovirus vector to deliver the antigens. Director of the Africa Health Research Institute (AHRI), Professor Willem Hanekom, explained that a vector is needed in order to stimulate the immune system’s response, and a viral vector is effective since it is foreign to the immune system, helping provoke an immune response. The virus is designed to simply carry the antigens into the body.
The AstraZeneca vaccine uses a modified chimpanzee adenovirus while Johnson & Johnson’s uses the human adenovirus Ad26, which has been used before in a number of vaccines including HIV. ImmunityBio’s vaccine uses the human adenovirus hAd5, which was initially used in failed gene therapy trials — but which proved to be an excellent vaccine delivery system. However, its development over the past two decades has been halting.
According to Prof Hanekom, if there is previous immunity against the adenovirus being used in a vaccine, the immune system will destroy it before the antigens inside are released. This has been circumvented with the ImmunityBio vaccine so that the immune system doesn’t immediately recognise the hAd5 vector. There was concern that the Johnson & Johnson vaccine would have limited efficacy in sub-Saharan Africa due to the fact that about half the population have immunity to Ad26.
“They’ve modified the adenovirus so it will still work and still be seen by the immune system even if there is pre-existing immunity because they’ve taken out the parts that the pre-existing immunity sees,” Prof Hanekom said.
Enhanced T-cell response
The vaccine is specifically designed to elicit strong T-cell responses to the nucleocapsid, and this has been seen in animal studies, Mentjes noted.
“Obviously one purpose of these studies is to see whether this design element generates those strong T-cell responses in humans as well,” he says. “All COVID vaccines elicit T and B cell responses, it’s not one or the other. But this (vaccine) is specifically designed to enhance those T-cell responses.”
B-cells and T-cells form part of the body’s adaptive immune response. B-cells form the antibodies to respond to a pathogen, and when the virus is introduced again, memory B-cells provide the antibodies to respond quickly.
Vardas says that with the ImmunityBio vaccine, B-cells and memory B-Cells will be formed that will remember the spike protein and the nucleocapsid and how to attack it. She likens this to a sniper attack. She explains that when a memory B-cell detects the spike or nucleocapsid protein, it signals for the production of B-cell antibodies. These antibodies then coat the outside of the virus, which signals the T-cells to attack and essentially “eat up” the virus-infected cells.
There are two types of T-cells, explains Vardas – CD4 cells which attack the virus, and CD8 cells, which also form a memory cell as the B-cell does. “You’ll have groups of CD4 and CD8 cells that are spike protein-specific and groups that are nucleocapsid specific, so improving that kind of attack to two sides of the war,” said Vardas.
A second generation viral vector COVID vaccine candidate from ImmunityBio Inc is being considered as a booster shot in a study involving nearly 500 000 South African health workers already innoculated with the Johnson & Johnson vaccine.
The health workers, who are the first outside of much smaller studies to receive vaccinations in South Africa, will need a booster, Glenda Gray, the co-lead of the South African studies, said in an interview Wednesday.
“It could be the universal boost that we are looking for,” she said. “Hopefully we will start in a couple of weeks.”
ImmunityBio’s second generation COVID vaccine candidate uses an hAd5 virus as vector. It induces both short term and long term immunity, and besides targeting the coronavirus’ spike proteins like first generation vaccines, it also targets the nucleocapsid protein, which has a lower rate of mutations. Additionally, this hAd5 vector virus provokes an anti-SARS-CoV-2 response, even in individuals with adenovirus immunity.
The magnitude of this T cell response was equivalent to those seen for spike and nucleocapsid T cell responses from previously infected convalescent SARS-CoV-2 patients.
The robust T cell response to both proteins could make it more effective against strains such as the B.1.351 ‘South African’ variant , ImmunityBio said in a statement earlier this year.
The vaccine is also being assessed to determine the safety and effectiveness of oral, sublingual and subcutaneous administration routes.
ImmunityBio’s vaccine is currently in phase I trials in Cape Town, and the company has signed an agreement with South Africa’s BioVac Institute to produce the inoculation in the country should it win approval.
A brief bout of anxiety was likely the cause of possible COVID vaccine-linked symptoms that people experienced, said researchers with the US Centers for Disease Control and Prevention say.
Several reports emerged in early April that people in at least five different vaccination sites in the US, all in different states, experienced symptoms almost immediately after receiving a vaccination jab.
These symptoms, all from people who received the Johnson & Johnson vaccine, were largely reported as being fainting, dizziness, lightheadedness, and rapid breathing. These incidents resulted in four of these sites being temporarily shut down, with pledges to investigate being made by both the CDC and local health officials.
The CDC investigation examined 64 cases documented across five vaccination sites between April 7 and 9, and interviewed providers who were at the sites when the events took place. Real-world safety data collected through the Vaccine Adverse Event Reporting System was also looked at.
While some people went to the hospital afterwards, none of the symptoms were deemed to be serious in severity, and most symptoms improved within 15 minutes. A total of 17 people experienced fainting, while more than half reported feeling lightheaded and dizzy and about a third experienced nausea and/or vomiting. Thirteen patients had also told staff members beforehand of past fainting due to a fear of needles or vaccines.
The CDC’s report on the investigation and its findings were published Friday in its Morbidity and Mortality Weekly Report (MMWR).
Fainting and similar short-term symptoms occasionally occurs following vaccination, and measures to reduce them are being investigated. In the CDC’s investigation of these cases and safety data doesn’t point to any other cause of these symptoms besides simple anxiety. In their report, the authors observed that these incidents took place before the more recent reports of a rare blood clotting condition possibly linked to the Johnson & Johnson vaccine were made known to the public. Use of the J&J vaccine has since resumed in many countries, with a warning of the risks.
Since the J&J vaccine is administered in a single dose, it’s possible that people who are more likely to be anxious about vaccines would also opt for it more often, which could then account for the higher incidence of vaccine-related fainting associated with the shot. Another possibility is that early media coverage of the first incidents on April 7 (or physically seeing someone faint) further increased people’s anxiety. However, it was widely reported that one of the first members of the public to take the Pfizer vaccine last December — a nurse — fainted right after. But the nurse pointed out at the time that she had a history of fainting.
The authors of the report summed it up in saying, “the stress of an ongoing pandemic might also increase anxiety surrounding covid-19 vaccination.”
Of course, fainting and these other symptoms can still be a scary experience, no matter the cause. And just because anxiety may be the root cause of these cases, that doesn’t mean there isn’t a real risk worth caring about.
Since fainting is still an upsetting experience no matter the cause and the risk of it should not be dismissed, so the authors recommend that people are routinely monitored after vaccination for at least 15 minutes. This is not only the chance that fainting may occur but other rare symptoms that could appear post-vaccination, such as a strong allergic reaction.