Genes may add to ethnic COVID-19 disparities; sickest patients unwell a year later

By Nancy Lapid

(Reuters) – Here is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Genes may explain some ethnic differences in COVID-19 impact

The varying impacts of COVID-19 among ethnic groups might be partially due to genetic differences in the cell-surface protein the virus uses as a gateway, an international research team found. They analyzed genetic information from more than 85,000 volunteers, including 6,274 who were tested for the new coronavirus and 1,837 who tested positive. In the gene for ACE2 – the “receptor” protein through which the virus breaks into cells – they found rare variants that would alter the part of the protein to which the virus attaches itself. These variant genes “appear to vary in frequency between different ethnic groups,” said Jamal Nasir of the University of Northampton in the UK. Two were more common in Europeans than in East Asians, for example. Nasir and colleagues also found variants that appear to increase or decrease an individual’s ACE2 protein levels, which could affect vulnerability to infection, or severity. People who were not infected with the coronavirus were more likely to have a variant that decreases ACE2 levels, according to a report posted on Wednesday on medRxiv ahead of peer review. The next steps, Nasir said, are to confirm the findings by exposing human cells to the virus in lab experiments and to identify small molecules that can be used as drugs to block harmful genetic mutations’ effects.

Severe COVID-19 still affects patients a year later

Among 1,276 COVID-19 patients hospitalized in China early in the pandemic, 49% still had at least one symptom 12 months after first becoming ill, researchers reported on Friday in The Lancet. Most common were fatigue or muscle weakness. About a third still had shortness of breath or other lung problems, especially those who had been the most severely ill. In some patients, doctors saw a reduced flow of oxygen from the lungs to the bloodstream. Roughly one in four survivors reported depression. Among patients who had been employed before they were hospitalized, 88% had returned to work by 12 months – but overall, the survivors were not as healthy as people from the community who had not been infected with the coronavirus. The study only looked at patients from one hospital, and not many of them had been sick enough to require intensive care. Nevertheless, the fact that some patients still had symptoms “should be taken into account when planning delivery of healthcare services post-pandemic,” coauthor Bin Cao from the China-Japan Friendship Hospital said in a statement.

Pfizer vaccine safe in small study of very sick kids

In adolescents with serious neurological conditions, the side effects of the Pfizer/BioNTech vaccine are likely to be mild to moderate and clear up quickly, a small study suggests. The 27 children in the study, ages 12 to 15, had muscular dystrophy, cerebral palsy, or other neurological diseases, plus other conditions such as heart defects and immune deficiency – all of which put them at very high risk for severe COVID-19. They would not have been included in the main trials of the vaccine because they were too sick, the researchers said. Eleven children had averse events after the first or second dose, such as mild rash, fever, headache, gastrointestinal upset, difficulty sleeping, and low blood sugar. Most problems resolved within 72 hours, and the rest cleared up within a week, according to a report published on Thursday in Archives of Disease in Childhood. Although the study involved only a few children, “these data are especially important as they are representative of the children who are most likely to benefit from vaccination, and parents and clinicians may have concerns regarding an increased risk of unexpected events,” the authors said.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)

Israel urges vaccination for all teens, citing Delta variant

JERUSALEM (Reuters) – An Israeli health official on Monday urged more 12- to 15-year-olds to be vaccinated against COVID-19, citing new outbreaks that he attributed to the more infectious Delta variant.

Israel expanded vaccine eligibility to include adolescents last month. Infections have fallen off sharply in recent weeks. Vaccination turnout has largely flatlined at around 55% of the 9.3 million overall population having received both shots, implying that adults have largely stopped getting vaccinated.

But COVID-19 recurrences were logged at two schools last week, contributing to a rise in the daily test positivity rate from a rolling one-month average of 0.1% to 0.3% on Saturday and 0.6% on Monday, Health Ministry data showed.

The ministry will probably issue a recommendation that 12- to 15-year-olds get vaccinated, having previously left the matter up to the parents’ preference, said Nachman Ash, the national pandemic response coordinator.

“I think that would certainly be correct at this stage, when we see an outbreak of the Delta variant in the country,” he told Tel Aviv radio station 103 FM.

“We should not wait for higher numbers. We have seen there were quite a few children infected over the last week.”

Separately, Israeli officials said they were considering the imposition of fines for parents whose unvaccinated children do not self-isolate upon coming into the country from abroad, as required.

Israel has been a world leader with its vaccine rollout and has been sharing data it collected with Pfizer, which provided the vaccines.

(Writing by Dan Williams; Editing by Mark Heinrich)

Moderna files for U.S. authorization to use its COVID-19 vaccine in teens

(Reuters) – Moderna Inc said on Thursday it has filed for U.S. authorization to use its COVID-19 vaccine in adolescents aged 12 through 17, potentially offering healthcare providers and pediatricians an easier-to-store shot ahead of the return-to-school season in the fall.

The company is the second drugmaker to seek regulatory nod for use of its vaccine in the age group, as the U.S. tries to vaccinate more young people.

Vaccinating children has been considered key to achieving “herd immunity” and while they mostly develop only mild COVID-19 symptoms or no symptoms, younger people still remain at risk of becoming seriously ill, and can spread the virus.

Moderna’s vaccine is already being used in the United States, the European Union and Canada for anyone over 18. The drugmaker said it has also submitted applications to European and Canadian regulators seeking authorization for the shot’s use in adolescents.

Last month, Moderna’s two-shot vaccine was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial which evaluated the vaccine in 3,732 teenagers.

The U.S. has already authorized Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for use in children as young as 12.

More than 7 million teens have received at least one dose of the vaccine in the United States, according to the U.S. Centers for Disease Control and Prevention.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru; Editing by Bernard Orr and Shounak Dasgupta)

More unvaccinated U.S. adolescents hospitalized; myocarditis may be rare vaccine side effect in teens

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 hospitalizations up among U.S. adolescents

COVID-19 hospitalizations rose among U.S. adolescents in March and April, and nearly a third of those hospitalized needed intensive care, according to data from more than 250 hospitals in 14 states released by the Centers for Disease Control and Prevention (CDC) on Friday. “Rates of COVID-19-associated hospitalization among adolescents also exceeded historical rates of seasonal influenza-associated hospitalization during comparable periods,” researchers reported in the CDC’s Morbidity and Mortality Weekly Report. The hospitals reported a total of 204 adolescents hospitalized for COVID-19 in March and April. “Until they are fully vaccinated, adolescents should continue to wear masks and take precautions when around others who are not vaccinated to protect themselves, and their family, friends, and community,” CDC Director Rochelle Walensky said in a statement on Friday. “I ask parents, relatives and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”

Heart inflammation may be rare vaccine side effect in teens

Temporary heart inflammation may be a rare side effect of the Pfizer/BioNTech COVID-19 vaccine in teenagers, according to pediatricians who reported on seven cases from across the United States. The previously healthy adolescents – all boys – developed chest pain within four days after their second dose. MRI exams showed myocarditis, or heart muscle inflammation. “Fortunately, none of our patients was critically ill,” the authors reported on Friday in Pediatrics. The boys’ symptoms resolved “rapidly” with medication. Measures of cardiac status had returned to normal at check-ups performed after one-to-three weeks. Myocarditis is a known rare adverse event following other vaccinations, the authors noted. There is no proof, however, that the vaccine caused these cases. “So far, over 2.2 million teenagers (aged) 16-17 have already received 2 doses of Pfizer vaccine, and over 3 million kids 12-15 years old have received dose #1,” said coauthor Dr. Judy Guzman-Cottrill of Oregon Health & Science University. “These are huge, very reassuring denominators.” COVID-19 itself can cause myocarditis, she noted. “After looking at the risks and benefits, the data support getting kids vaccinated.”

Measuring longer-lasting COVID-19 immunity feasible

Along with testing for antibody levels after COVID-19 or vaccination to gauge a person’s immunity to the virus, measuring the response of the immune system’s T cells could provide important information, according to researchers based at Cardiff University. While antibody levels wane over time, T cell responsiveness can last for months or years. But T cells have been harder to measure in cost-effective ways. Adapting a method widely employed to measure immune responses to other types of infections, the researchers took blood samples from adults and children and stimulated T cells with small proteins specific to the SARS-CoV-2 virus. T cells that recognize these proteins, because the person has been previously infected or vaccinated, “are triggered to produce chemicals like interferon which can be easily measured,” said study coauthor Andrew Godkin. The results were about 96% accurate, researchers reported on Tuesday on medRxiv ahead of peer review. “The test is very sensitive and seems to be accurate at identifying people previously exposed to the virus,” Godkin said. “The test is widely available, easy to employ, and should play a very useful role in monitoring this pandemic.”

Virus unlikely to insert genetic fragments into patients’ genetic code

A new study refutes the controversial claim made by researchers last month in PNAS that small fragments of genetic instructions from the coronavirus became integrated into the genome of infected cells, in test tube experiments. In principle, coronavirus RNA generated by such integrated snippets, while probably not harmful, might cause positive COVID-19 PCR tests long after a patient has recovered, the authors of that study said. But when researchers in Australia sought to find signs of SARS-CoV-2 genetic code integrated into the DNA of infected cells, they could not find any. “This was despite using the same sequencing technology and cell type (as in the PNAS study) and performing substantially more DNA sequencing,” said Geoffrey Faulkner of the University of Queensland. The new finding were posted on Sunday on bioRxiv ahead of peer review. The researchers did find copies of hepatitis B virus integrated into liver tissue, and copies of other DNA elements integrated into the cells they experimented with, “suggesting our approach would have found SARS-CoV-2 copies” if they were present, he said. His team agrees with others who suggest the PNAS findings may have reflected unintended effects of experimental methods. “We think SARS-CoV-2 integration into DNA is possible in human cells even if it is likely to be incredibly rare in patients,” Faulkner said.

(Reporting by Nancy Lapid and Christine Soares; Editing by Bill Berkrot)

Post vaccination infection rare but possibly contagious; study refutes another anti-vax pregnancy claim

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.

Breakthrough infections rare, but potentially contagious

As of April 30, when roughly 101 million Americans had been fully vaccinated against COVID-19, “breakthrough” infections had been reported in 0.01% of them, the U.S. Centers for Disease Control and Prevention (CDC) reported on Tuesday. Roughly 27% of breakthrough infections were asymptomatic, while in 2% of cases, patients died. The CDC had genetic data for virus samples from 555 breakthrough infections. Mutated variants of the coronavirus, including those first seen in the UK and South Africa, accounted for 64% of the breakthroughs. In a separate study posted Tuesday on medRxiv ahead of peer review, researchers reported that among 20 fully-vaccinated healthcare workers with breakthrough COVID-19 cases, all were infected with variants. An earlier study had linked breakthrough infections with low viral loads, suggesting low transmission risks, but “we found many samples in our breakthrough cohort with high viral load,” said coauthor Pavitra Roychoudhury of the University of Washington. “Our work suggests that not all breakthrough infections are at low risk of initiating transmission and, if they did, these infections could lead to the continued spread of variants of concern, particularly in areas with low vaccination rates.”

Study refutes anti-vaxxers’ pregnancy, breast milk claims

Unfounded claims by anti-vaccine activists that COVID-19 shots from Pfizer/BioNTech and Moderna will damage the placenta and contaminate breast milk have been refuted by new data. The vaccines deliver synthetic messenger RNA (mRNA), which instructs the body to make proteins that in turn induce antibodies to attack the coronavirus. Anti-vaxxers claim, with no evidence, that mRNA also induces antibodies that attack a protein called syncytin-1, which is important for the developing placenta during pregnancy. They also claim mRNA from the vaccines ends up in breast milk. When researchers studied blood samples from 15 women who received at least one dose of the Pfizer/BioNTech vaccine – including two pregnant women and five who were breastfeeding – they saw coronavirus antibodies but no antibodies against syncytin-1. None of the breastfeeding women had vaccine mRNA in their milk, according to a report posted Tuesday on medRxiv ahead of peer review. “This small study tells us that it is unlikely that COVID-19 mRNA vaccination will cause complications in pregnancy or fertility through cross-reacting antibodies against syncytin-1, or for breastfed infants through breast milk,” the authors said.

Vaccines appear safe for “long COVID” survivors

COVID-19 survivors with lingering symptoms can safely be vaccinated against the coronavirus, a small study suggests. Researchers tracked 36 individuals with “long COVID” who had been hospitalized while acutely ill and who later received at least one dose of either the Pfizer/BioNTech or AstraZeneca vaccine. Eight months after admission to the hospital, and before vaccination, participants had at least one lingering symptom and half had at least four symptoms. Before vaccination, their quality-of-life was “markedly reduced” from normal, the researchers reported on Monday in Annals of Internal Medicine. One month after vaccination, 71% of their symptoms remained unchanged, 23% of their symptoms were improved, and 6% of symptoms had worsened. There was no significant worsening in quality-of-life or mental well-being, and outcomes were similar with both vaccines, researchers reported. The results may reassure people with persistent COVID-19 symptoms that the different types of vaccines developed by Pfizer/BioNTech or AstraZeneca are “not associated with a decrease in quality of life or worsening of symptoms,” the researchers said.

Moderna says vaccine safe, effective in adolescents

Moderna’s COVID-19 vaccine was 100% effective in a trial involving 3,732 adolescents aged 12-17, with no major safety problems, the company said on Tuesday. Among participants who received two doses, there were no cases of COVID-19 compared with four cases among those who received a placebo. After only one dose, the vaccine was 93% effective in this age group, Moderna said. Side effects were similar to those reported in earlier studies, including headache, fatigue, body aches and chills. Moderna plans to submit the findings to regulators for emergency use authorization in June. The U.S. Centers for Disease Control and Prevention (CDC) said on Monday it is monitoring rare reports of mild heart inflammation after COVID-19 vaccination in adolescents. The CDC said the condition is not occurring at higher rates than would be expected in the general population, so no causal link to the vaccine has been established. Dr. Amesh Adalja of the Johns Hopkins Center for Health Security said even if vaccines turn out to be the cause, it is important to consider the risk-benefit ratio. “Vaccines are going to unequivocally be much more beneficial,” outweighing any low risk of myocarditis, he said.

(Reporting by Nancy Lapid, Julie Steenhuysen and Radhika Anilkumar; Editing by Bill Berkrot)

U.S. CDC panel backs COVID-19 vaccine now cleared for adolescents

By Michael Erman and Manojna Maddipatla

(Reuters) -U.S. states are set to begin using the vaccine from Pfizer Inc and BioNTech SE to inoculate younger adolescents against COVID-19 after advisers to the U.S. Centers for Disease Control and Prevention (CDC) backed the plan in a unanimous vote on Wednesday.

The U.S. Food and Drug Administration on Monday authorized the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps, and the action by the CDC group is an important, but not required, final seal of federal regulatory approval.

Some states, including Georgia, Delaware and Arkansas, began offering the vaccine to younger teens on Tuesday.

The Advisory Committee on Immunization Practices (ACIP), which provides recommendations to the CDC, voted 14-0 to back the vaccine, after reviewing trial evidence that showed no one in the 12-15 age group who received the vaccine got COVID-19, and there were no cases of Bell’s Palsy or severe allergic reactions.

Moreover, the vaccine produced robust antibody responses in the age group and showed 100% efficacy in the trial, with no cases of symptomatic COVID-19 among the fully vaccinated adolescents.

“This will provide protection for 12 to 15 year old’s,” said Dr. Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their family. It will contribute to community immunity, and it allows the kids to more safely go back to camps this summer, and back for in-person school.”

About a third of all Americans have been fully-vaccinated according to the CDC data. But the pace of vaccination has slowed in the recent weeks.

The rollout of a vaccine for adolescents should help further limit the spread of the virus at a time when more contagious variants are circulating, and could shorten the road to normalcy for Americans.

“I think we should be in full school, full in-person school, in the fall,” CDC Director Rochelle Walensky said at a CNBC health summit on Tuesday.

Children have been considered by health officials as being at a lower risk for severe COVID-19, but they can still spread the virus. More than 1.5 million cases have been reported among 12- to 17-year-olds, and as more adults become vaccinated, adolescents are accounting for a higher proportion of total cases.

Adjusted for underreporting, the working group estimated 22.2 million U.S. COVID-19 infections in those aged 5 to 17.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group – half of whom were given placebo – were tested as an expansion of Pfizer’s more than 46,000-person trial.

The committee will hear from Pfizer about the vaccine’s safety and efficacy in adolescents and will consider the views of a handful of CDC officials on its implementation.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer, Peter Henderson and Bill Berkrot)

U.S. FDA set to authorize Pfizer COVID-19 shot for ages 12-15 early next week – NYT

(Reuters) – The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year old’s is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, with data from Moderna’s trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

By Michael Erman and Mrinalika Roy

(Reuters) – Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15.

The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year old’s in a clinical trial.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12 to 15 year olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, and data from Moderna’s trial could come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts.

Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12- to 15-year old’s in the coming days.