Tag Archives: side effects

Lack of side effects doesn’t mean mRNA vaccine not working; mRNA shots limit breakthrough infection severity

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Lack of vaccine side effects no cause for concern

While a variety of side effects after receiving an mRNA COVID-19 vaccine may be a sign of the immune system kicking into high gear, a lack of such reactions does not mean it has failed to respond, researchers have found. They tested 206 hospital employees for antibodies against the coronavirus before and after receipt of the vaccine from Pfizer and BioNTech and surveyed them about vaccine-related reactions. As in clinical trials, arm pain was the most common symptom, reported by 91% after the first shot and 82% after the second. Systemic symptoms, such as feeling weak or tired, or having body aches or pains, were reported by 42% and 28%, respectively, after the first shot and by 62% and 52% after the second shot. But there was no correlation between vaccine symptom severity and antibody levels one month after vaccination, the researchers reported on Friday in a paper posted on medRxiv ahead of peer review. The researchers said the findings should reassure people that a lack of side effects after getting the mRNA shots does not mean the vaccine is not working as intended. The Moderna shot also uses mRNA technology.

mRNA vaccines limit severity of rare breakthrough infections

In the rare cases of COVID-19 that occur after vaccination, patients are likely to be sick for less time and have milder symptoms than if they were unvaccinated, according to a U.S. study of nearly 4,000 healthcare personnel, first responders, and other frontline workers. In participants who were tested weekly since mid-December, COVID-19 has been diagnosed in five who were fully vaccinated with an mRNA vaccine from either Pfizer and BioNTech or Moderna, 11 who were partially protected, having received either one shot or were less than 14 days out from their second, and 156 who were unvaccinated. Most unvaccinated patients were sick for at least two weeks, compared with only one week for vaccinated patients, the researchers reported on Wednesday in The New England Journal of Medicine. Patients who were fully or partially vaccinated had 58% lower odds of fever and spent an average of 2.3 fewer days in bed than unvaccinated patients. Their viral loads also averaged 40% lower. “If you get vaccinated, about 90% of the time you’re not going to get COVID-19,” coauthor Dr. Jeff Burgess of the University of Arizona said in a statement. “Even if you do get it, there will be less of the virus in you and your illness is likely to be much milder.”

J&J vaccine shows promise against Delta variant in lab test

The single-shot COVID-19 vaccine from Johnson & Johnson showed promise against the highly contagious Delta coronavirus variant in a laboratory study posted on Thursday on bioRxiv ahead of peer review. Analyses of blood from eight recipients of the vaccine showed that its neutralizing antibody activity against the Delta variant, first identified in India, was reduced by 1.6-fold compared to an earlier version of the virus but is still higher than against the Beta variant, first identified in South Africa. In trials last year while the Beta variant was circulating in South Africa, the J&J vaccine showed 66% efficacy against moderate and severe disease. “We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant,” J&J Chief Scientific Officer Paul Stoffels said. So far, preliminary data has shown that vaccines made by Pfizer and BioNTech, AstraZeneca and Moderna are largely protective against Delta, with the concentration of virus-neutralizing antibodies being somewhat reduced. Delta has become the variant of most concern around the world as it is more easily transmitted, may lead to more severe disease even in younger people, and is becoming the dominant virus version in many countries.

High COVID-19 rate seen in patients’ pets

In 20% of households where humans had COVID-19 or had recovered from it, cats and dogs also had antibodies to the virus, researchers from The Netherlands found. They visited 196 households where humans had tested positive within the previous 200 days, to test pet cats and dogs for the coronavirus and for antibodies that would indicate past infection. Thirteen animals – six cats and seven dogs – or 4.2%, had COVID-19, and 54 – 31 cats and 23 dogs (17.4%) – had coronavirus antibodies. There was no evidence that pets were passing the infection to each other. Owners reported no or mild symptoms in the infected animals. “If you have COVID-19, you should avoid contact with your cat or dog,” Dr. Els Broens of Utrecht University, whose team presented the data on Wednesday at the European Congress of Clinical Microbiology & Infectious Diseases, said in a statement. “The main concern, however, is not the animals’ health … but the potential risk that pets could act as a reservoir of the virus and reintroduce it into the human population.” To date, however, no pet-to-human transmission has been reported, he added. “It seems unlikely that pets play a role in the pandemic.”

(Reporting by Nancy Lapid, Aakriti Bhalla and Manas Mishra; Editing by Bill Berkrot)

Meat-free diet may lower severe disease risk; no serious problems found with AstraZeneca shot in Scotland

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

COVID-19 severity linked with diet

People on meat-free diets had lower odds of contracting moderate to severe COVID-19, according to a six-country study published on Monday in BMJ Nutrition, Prevention & Health. Plant-based diets were tied to a 73% lower risk of severe disease, researchers found in a survey of 2,884 healthcare providers who cared for COVID-19 patients. Combining those on a plant-based diet and people who also ate fish but no meat, researchers found 59% lower odds of severe disease. The study cannot prove that specific diets protected against severe COVID-19, and diet did not appear to lower the risk of becoming infected. But plant-based diets are rich in nutrients, vitamins and minerals that are important for healthy immune systems, the researchers noted, and fish provide vitamin D and omega-3 fatty acids, which have anti-inflammatory properties. Healthy eating, however, has been problematic during the pandemic, according to two presentations this week during a virtual meeting of the American Society for Nutrition. Consumption of healthy foods such as vegetables and whole grains declined, according to researchers who compared the diets of more than 2,000 Americans before and during the pandemic. In a separate study, researchers who collected dietary data in June 2020 for 3,916 U.S. adults found many had increased their consumption of unhealthy snacks, desserts and sugary drinks during the pandemic. “Individuals may need help to avoid making these dietary changes permanent,” said Dr. Sohyun Park of the U.S. Centers for Disease Control and Prevention, coauthor of the latter study.

No serious problems with AstraZeneca vaccine in Scotland

A study of side effects from AstraZeneca’s COVID-19 vaccine in Scotland found only an association with a largely harmless bleeding condition and no link to the potentially deadly venous clotting in the brain, known as CVST, which has caused concern in Europe and led to pauses in its use. Researchers who tracked 5.4 million people in Scotland found roughly one additional case of idiopathic thrombocytopenic purpura (ITP) per 100,000 people after the first AstraZeneca shot. ITP is a treatable condition of low platelet count and has not caused any deaths among the 1.7 million recipients of the vaccine in the study, the authors reported on Wednesday in Nature Medicine. Due to the rarity of CVST, the Scottish study may have been too small to allow for any conclusions, coauthor Aziz Sheikh of the University of Edinburgh told a media briefing. “The overall message is just the rarity of these outcomes,” said Sheikh. “This is reassuring data.”

Aspirin does not help hospitalized COVID-19 patients

Aspirin did not improve survival or reduce disease severity in a study of nearly 15,000 patients hospitalized with COVID-19. Researchers had hoped that because aspirin helps reduce blood clots in other diseases, it might be helpful in COVID-19 patients who are at a higher risk for clotting issues. Patients randomly assigned to receive 150 milligrams of aspirin once a day did have fewer blood clots, but no lower risk of becoming sicker and requiring mechanical ventilation or better odds of being alive after 28 days. And they had a higher risk of major bleeding complications, a not uncommon issue with aspirin therapy. They did have slightly better odds of getting out of the hospital alive, researchers reported on medRxiv on Tuesday ahead of peer review. But “this does not seem to be sufficient to justify its widespread use for patients hospitalized with COVID-19,” said Peter Horby of the University of Oxford, co-chief investigator of the trial.

COVID-19 control policies still needed in warm weather

In the absence of lockdowns and social distancing, weather and crowding have the biggest impact on COVID-19 spread, a new study found. But even if virus transmission tends to be somewhat lower in warmer conditions, summer weather “cannot be considered a substitute for mitigation policies,” because population density matters more than temperature, according to the report from Imperial College London published on Wednesday in PNAS. Warmer regions should not expect to ease mobility restrictions before colder regions, especially because “warmer regions tend to have higher population densities – for example, the population in Florida is more densely packed than in Minnesota,” coauthor Will Pearse said in a statement. Lockdowns have stronger effects than either temperature or population density, his team reported. Because temperature changes have a much smaller effect on transmission than policy interventions, “while people remain unvaccinated, governments mustn’t drop policies like lockdowns and social distancing just because a seasonal change means the weather is warming up,” said coauthor Dr. Tom Smith. The study also suggests “that lower autumn and winter temperatures may lead to the virus spreading more easily in the absence of policy interventions or behavioral changes.”

(Reporting by Nancy Lapid, Megan Brooks, Ludwig Burger, and Vishwadha Chander; Editing by Bill Berkrot)

Third-trimester vaccination appears safe; Pfizer/BioNtech vaccine effective in those with chronic illnesses

By Nancy Lapid

(Reuters) -The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Third-trimester vaccination appears safe in early data

Among pregnant women who received COVID-19 vaccines manufactured by Pfizer Inc and BioNTech SE or Moderna Inc and who signed up for an online survey, side effects were no different than what has been seen in the general population, researchers reported Wednesday in The New England Journal of Medicine. But they noted that data of this nature is still sparse. They looked at responses from smartphone users who participated in the U.S. Centers for Disease Control and Prevention (CDC) “v-safe” program, which collects information on COVID-19 vaccination experiences. Compared to non-pregnant women, the 35,691 pregnant responders reported more injection site pain but fewer headaches, muscle aches, chills, and fevers. Among 3,958 women who signed up for a CDC pregnancy registry, no one vaccinated in the first trimester has given birth yet. The Vaccine Adverse Event Reporting System (VAERS), run jointly by the CDC and the U.S. Food and Drug Administration, has recorded 46 miscarriages potentially related to COVID-19 vaccination, including 37 in the first trimester, the researchers said. “Early data from the v-safe surveillance system, the v-safe pregnancy registry, and the VAERS do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with Covid-19 vaccination in the third trimester of pregnancy,” researchers concluded.

Pfizer/BioNTech vaccine effective in people with chronic illnesses

The Pfizer/BioNTech COVID-19 vaccine is effective at preventing symptomatic and severe disease in people with some chronic illnesses, like diabetes and heart disease, according to a large real-world study published on Wednesday in The New England Journal of Medicine. The analysis of almost 1.4 million people, conducted by Clalit, Israel’s largest healthcare provider, showed the vaccine was 80% effective against symptomatic infection for people with heart or chronic kidney diseases, 86% for people with type 2 diabetes, 75% for cerebrovascular disease, and 84% for people suffering from immunodeficiency. For vaccinated people with at least three chronic conditions or risk factors, the vaccine was 88% effective in preventing symptomatic infection. It was more than 90% effective against severe disease for people with type 2 diabetes, heart or cerebrovascular disease. The results were lower than the 95% overall vaccine effectiveness observed after the second dose in clinical trials last year. “These results are very encouraging, as they suggest that most COVID-19 cases will be prevented by vaccination even in the elderly and chronically ill,” said Ran Balicer, Clalit’s chief innovation officer.

Fever, shortness of breath are COVID-19 red flags in pregnancy

Pregnant women with COVID-19 and their newborns face “consistent and substantial increases” in risks of complications, an international study has found. COVID-19 in newborns is associated with a three-fold risk of severe medical complications, according to the study by scientists at the University of Oxford. And pregnant women with symptomatic COVID-19 face higher risks of preterm delivery, preeclampsia (high blood pressure with organ failure risk), need for intensive care and death. That was particularly true for women with fever and shortness of breath, according to a report published on Friday in JAMA Pediatrics. “Women with COVID-19 during pregnancy were over 50% more likely to experience pregnancy complications compared to pregnant women unaffected by COVID-19,” said co-author Aris Papageorghiou. The study, conducted in 18 countries, included 706 pregnant women with COVID-19 and 1,424 similarly pregnant women without COVID-19 who were giving birth at the same hospital. Findings also showed a delivery by Caesarean section may be associated with an increased risk of virus infection in newborns. Breastfeeding, however, does not seem to heighten risks of transmission from mothers to babies, they found.

(Reporting by Nancy Lapid and Maayan Lubell; Editing by Bill Berkrot)

As globe gallops into vaccine trials, insurers remain unfazed

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigor.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four years.

“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty.

This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.

Gallagher said premiums in Britain, for example, started at about 5,000 pounds ($6,500) per trial.

Total claims limits in policies were typically set at roughly $6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.

In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).

‘LOSS EXPERIENCE NOT DRAMATIC’

However part of the reason why premiums have not risen as sharply as some people might have expected is that claims from trial are generally uncommon, according to executives. This is because patients have often signed so-called informed consent agreements, they said.

Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.

“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.

“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”

Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than side-effects of the treatment, executives said.

Such have been the worries about the vaccine race among some members of the public, who fear safety standards could slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process”.

ASTRAZENECA TRIAL SUSPENSION

AstraZeneca and Oxford University’s suspension of global Phase III trials of their experimental COVID-19 vaccine early last month due to a participant’s illness brought the risk of side effects in clinical trials to the public fore.

But the insurers said such delays were not unexpected, and could even reflect the extra caution of vaccine developers given the lack of data about COVID-19.

“Side effects always happen with clinical trials, but these are typically mild and expected. It is not very common to delay or suspend trials, it does happen though,” said Piazzi at AGCS, whose main peers in underwriting trials include Chubb, HDI and Fairfax’s Newline.

“Pharma companies and insurers alike are even more careful than usual with COVID-19 trials because there is so much at stake, particularly for the patients’ safety.”

All trials of the vaccine candidate have resumed, with the exception of the U.S. study.

There have been examples in recent memory of drug trials going catastrophically wrong, though.

In 2016, for instance, one participant died and five were hospitalized in a Phase I trial run by French company Biotrial in the city of Rennes, testing an experimental mood brightener made by Portuguese drugmaker Bial.

In 2006, six patients required intensive care after receiving a potential treatment against leukemia and auto-immune disease in London. One was described as looking like “the elephant man” after his head swelled. Another lost fingertips and toes. Germany’s TeGenero, the initial developer of the medicine, folded.

But insurance executives stress such disasters are rare, given the thousands of clinical drug trials being carried out every year.

Walters of Aon, speaking about the 2016 trial, said it was “obviously a horrible situation”.

“But that’s one of very few incidents of really bad loss experience that the industry has faced. So, clinical trial insurance is not hugely expensive. Let’s put it that way.”

(Reporting by Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger; Editing by Pravin Char)