AstraZeneca antibody cocktail study shows success treating COVID-19

By Ludwig Burger, Yadarisa Shabong and Sachin Ravikumar

(Reuters) -AstraZeneca’s antibody cocktail against COVID-19, which has proven to work as a preventative shot in the non-infected, was also shown to save lives and prevent severe disease when given as treatment within a week of first symptoms.

The drug, a combination of two antibodies called AZD7442, reduced the risk of severe COVID-19 or death by 50% in non-hospitalized patients who have had symptoms for seven days or less, the Anglo-Swedish drugmaker said on Monday.

The risk reduction was even better in patients who started therapy within just five days of initial symptoms, but AstraZeneca joins an already crowded field of medicines that were shown to prevent deterioration in patients with mild disease when given soon after diagnosis.

AstraZeneca executive Mene Pangalos said in a media call that the treatment results would mainly underscore the potential future use as a non-vaccine prevention.

“If and when this is approved it will be used in the treatment setting as well. But the real differentiator for this antibody is going to be in the prophylactic setting,” he said.

Similar therapies made with a class of drugs called monoclonal antibodies are being developed by Regeneron, Eli Lilly and GlaxoSmithKline with partner Vir. These therapies are approved for emergency use in the United States for treating mild-to-moderate COVID-19.

Regeneron’s therapy showed 72% protection against symptomatic infection in the first week, and 93% after that.

GSK-Vir’s showed a 79% reduction in the risk of hospitalization or death due to any cause, while Eli Lilly’s therapy showed a 70% reduction in viral load at day seven compared to a placebo.

Merck & Co Inc, in turn, is emphasizing the convenience of use of its anti-COVID-19 tablet, which cut the risk of having to got to hospital or of dying by 50% in a trial of early-stage patients who had at least one risk factor.

Merck, collaborating with Ridgeback Biotherapeutics, on Monday applied for U.S. emergency clearance for the oral drug.

AstraZeneca, whose COVID-19 vaccine has been widely used across the globe, asked U.S. regulators last week to grant emergency use authorization for AZD7442 as a preventative shot.

As such, it is designed to protect people who do not have a strong enough immune response to vaccines, primarily those who have received organ transplants or who are in cancer care.

If full market clearance is obtained after any emergency approval the market could widen, for instance, to include crew and passengers of a cruise ship, said Pangalos.

“You can say the same for people who don’t want to be vaccinated but want an antibody,” he added.

AstraZeneca said it is submitting the new treatment data on AZD7442 to global health regulators.

The trial took place across 13 countries and involved more than 900 adult participants, 90% of whom suffered from conditions that made the particularly vulnerable to COVID-19, such as cancer and diabetes. One half receiving AZD7442 and the rest a placebo.

Full trial results will be submitted for publication in a peer-reviewed journal, AstraZeneca said.

AZD7442 contains laboratory-made antibodies designed to linger in the body for months to contain the virus in case of an infection. A vaccine, in contrast, relies on an intact immune system to develop targeted antibodies and infection-fighting cells.

While Monday’s results cover the use of AZD7442 in non-hospitalized patients, a separate trial is also studying its use as a treatment for hospitalized COVID-19 patients.

(Reporting by Ludwig Burger in Frankfurt, Yadarisa Shabong in Bengaluru; Editing by Saumyadeb Chakrabarty, Kirsten Donovan and Alexander Smith)

Vietnam to mix doses of Pfizer, AstraZeneca COVID-19 vaccines

HANOI(Reuters) – Vietnam will offer the coronavirus vaccine jointly developed by Pfizer and BioNTech as a second dose option for people first inoculated with the AstraZeneca vaccine, the government said on Tuesday.

Vietnam’s mass inoculation campaign is in its early stages, with fewer than 300,000 people fully vaccinated so far. It has so far used AstraZeneca’s viral vector vaccine and last week took delivery of 97,000 doses of the Pfizer-BioNTech mRNA shot.

“Pfizer vaccines will be prioritized for people who were given first shot of AstraZeneca 8-12 weeks before,” the government said in a statement.

Several countries, including Canada, Spain and South Korea, have already approved such dose-mixing mainly due to concerns about rare and potentially fatal blood clots linked to the AstraZeneca vaccine.

A Spanish study found the Pfizer-AstraZeneca combination was highly safe and effective, according to preliminary results.

But the World Health Organization’s chief scientist advised on Monday against mixing and matching COVID-19 vaccines, calling it a “dangerous trend” since there was little data available about the health impact.

The Vietnamese government in a separate statement said its health ministry was in talks with India to secure 15 million doses of COVID-19 vaccine Covaxin.

The country has so far received around 8 million doses of vaccines from multiple sources, including international COVAX scheme, donations and its own purchases.

Vietnam has been trying to expedite its vaccination campaign as the pace of infections grow, having hit daily records eight times this month. It reported 2,031 new infections on Tuesday, most of those in the epicenter Ho Chi Minh City.

Prior to May 2021, it had recorded less than 3,000 coronavirus cases in total. Its caseload is now 34,500, with 130 deaths.

Vietnam said on Tuesday it would soon receive 1.5 million doses of the AstraZeneca vaccine donated by Australia and an additional batch of one million doses of the vaccine from Japan this week.

(Editing by Ed Davies and Martin Petty)

Pandemic tied to spike in diabetes in children; type of immune response lasts months after Pfizer/BioNTech vaccine

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.

Pandemic tied to sharp rise in type 2 diabetes in kids

Hospitalization rates for children with newly diagnosed type 2 diabetes more than doubled during the pandemic, two hospitals reported at the American Diabetes Association Scientific Sessions, held virtually this year. At Our Lady of the Lake Children’s Hospital in Baton Rouge, Louisiana, children with newly diagnosed type 2 diabetes accounted for 0.62% of inpatients from March through December 2020, up from 0.27% the year before. Those numbers are low, “but just the fact that this rate has more than doubled over the past year is … significant,” said Dr. Daniel Hsia of Pennington Biomedical Research Center in Baton Rouge. Children hospitalized in 2020 had more severe diabetes, with higher blood sugar and more dehydration, than children admitted in the prior year, he said. At Children’s National Hospital in Washington, DC, cases of new-onset type 2 diabetes in children increased 233% from 2019 to 2020 – and the children were sicker than in previous years, a separate team reported. Most of these children at both hospitals had not previously had COVID-19. Social distancing measures may have kept children from having regular physical activity and contributed to weight gain, and also kept parents from taking them for routine medical care, all of which may have contributed to more severe illness, researchers speculated. “Our study reinforces the importance of maintaining a healthy lifestyle for children even under such difficult circumstances” Hsia said in a statement.

Immune cell “factories” work longer after mRNA vaccines

The tiny “factories” in lymph nodes that churn out antibody-producing B cells to fight infections, called germinal centers, were still functioning to hold COVID-19 at bay for months after people received the mRNA vaccine from BioNTech and Pfizer, according to a new study. After most vaccines, germinal centers last only a few weeks. “Germinal centers are the key to a persistent, protective immune response,” said Ali Ellebedy of Washington University School of Medicine in St. Louis, who coauthored a report on Monday in Nature. “Germinal centers are where our immune memories are formed. And the longer we have a germinal center, the stronger and more durable our immunity will be because there’s a fierce selection process happening there, and only the best immune cells survive.” Researchers studied cells from germinal centers in armpit lymph nodes of 14 recipients of the Pfizer/BioNTech vaccine. Three weeks after the first dose, all 14 had germinal centers that were still generating B cells. B-cell production “expanded greatly” after the second shot and stayed high, they reported. Eight of 10 people biopsied 15 weeks after the first dose, still had functioning germinal centers. “We’re still monitoring the germinal centers, and … in some people, they’re still ongoing,” Ellebedy said. “This is truly remarkable.” The same effect is likely also true for Moderna’s mRNA vaccine, the researchers believe. Ultimately, immune cells called T cells are what sustains the germinal centers’ work after they disappear. The researchers plan next to investigate the magnitude and durability of T cell responses after mRNA COVID-19 vaccines.

Following AstraZeneca with Pfizer shot boosts antibody response

Giving a dose of the Pfizer/BioNTech COVID-19 vaccine four weeks after an AstraZeneca shot produces better immune responses than a second dose of AstraZeneca’s, Oxford University researchers said on Monday. In a study of 830 older adults, mixed two-dose schedules of AstraZeneca and Pfizer vaccines produced higher concentrations of antibodies against the coronavirus that a full schedule of the AstraZeneca shot. The most effective approach – two doses of Pfizer/BioNTech mRNA vaccine – produced levels of antibodies about 10 times higher than two doses of the AstraZeneca vaccine, the researchers reported on Friday in a Lancet preprint. However, the AstraZeneca shot followed by a Pfizer jab induced antibody levels about as high as two Pfizer/BioNTech doses. Giving the Pfizer shot first, followed by AstraZeneca’s, was not as successful. That combination yielded antibody levels higher than two AstraZeneca shots but lower than two doses of the Pfizer vaccine. There were no new safety issues uncovered in the study. Matthew Snape, the Oxford professor behind the trial, said the findings could be used to give flexibility to vaccine rollouts but were not significant enough to recommend a broad shift away from clinically approved schedules.

COVID-19, not Pfizer’s vaccine, tied to Bell’s palsy

The Pfizer/BioNTech vaccine has not been linked with a higher risk for the facial nerve paralysis known as Bell’s palsy, but COVID-19 itself does increase the risk, suggest two separate studies published on Thursday in JAMA Otolaryngology-Head and Neck Surgery. One study involved 110 people in Israel who received the Pfizer vaccine, including 37 in whom the characteristic facial droop developed on average nine days after the first dose or 14 days after the second. After accounting for underlying risk factors for Bell’s palsy, the researchers concluded the vaccine itself did not increase the risk. Furthermore, they found, rates of Bell’s palsy had not gone up during the vaccine rollout. In the second study, researchers compared Bell’s palsy rates among roughly 348,000 patients with COVID-19 and roughly 63,500 people who had been vaccinated against the coronavirus. The Bell’s palsy risk was nearly seven times higher in those with COVID-19, they found. “Our data suggest that rates of facial nerve palsy are higher in patients who are positive for COVID-19, and this incidence exceeds the reported incidence of Bell’s Palsy with the COVID-19 vaccine,” said Dr. Akina Tamaki of University Hospitals Cleveland Medical Center, who coauthored that study. “Taken together, it supports that the vaccine is safe from a facial nerve paralysis standpoint.”

(Reporting by Nancy Lapid, Megan Brooks, Marilynn Larkin and Alistair Smout; Editing by Bill Berkrot)

AstraZeneca commits to 1.8 million Thai vaccine doses amid supply anxiety

By Patpicha Tanakasempipat

BANGKOK (Reuters) – Drugmaker AstraZeneca said on Wednesday it would soon provide Thailand with 1.8 million doses of locally manufactured COVID-19 vaccine, the first of multiple batches this month, just days away from the launch of the country’s vaccination drive.

The joint announcement by AstraZeneca and Siam Bioscience, a firm owned by Thailand’s king, comes amid public anxiety about vaccine supplies, as the country suffers its most severe outbreak so far.

It did not say whether the Thai plant would make all 6 million doses that Thailand’s government has promised would be available this month.

The government’s mass immunization drive starts on Monday and relies almost entirely on its reserved 61 million doses of AstraZeneca vaccine, most of which it said would come from Siam Bioscience, which is making vaccines for the first time.

Questions about Siam Bioscience meeting production targets are sensitive because King Maha Vajiralongkorn is its sole owner. Insulting Thailand’s monarchy is a crime punishable by up to 15 years in prison.

AstraZeneca has partnered with the Thai firm for the manufacture of 200 million doses for use in Southeast Asia, a region with low COVID-19 immunization rates that is seeing a strong resurgence of the virus.

Thailand is seeking 100 million doses of coronavirus vaccine this year in total.

Thai health minister Anutin Charnvirakul said on Wednesday the promised 6 million doses would come this month “as planned”, but specified no delivery dates or the number to be sourced locally.

Anutin also said Thailand will get an additional 11 million doses of Sinovac vaccines before August. Thailand has used the Chinese vaccine for most of its early inoculations of frontline workers.

“We will get AstraZeneca vaccine. It may come from wherever, but all AstraZeneca just the same. It could be made in Thailand or imported from overseas. It depends on AstraZeneca’s supply chain,” Anutin told reporters.

Siam Bioscience has not answered queries from Reuters on its production targets.

AstraZeneca said 1.8 million locally produced doses would be delivered by Monday, the first of multiple deliveries this month.

It said deliveries of Thai-made doses to other Southeast Asian countries would start in July.

The first delivery to the Philippines, which was promised 17 million doses, was cut from 1.3 to 1.17 million doses and delayed from late June to mid-July, a Philippine presidential advisor told Reuters on Tuesday, citing Thai production delays.

(Reporting by Patpicha Tanakasempipat; Additional reporting by Panarat Thepgumpanat and Panu Wongcha-um; Editing by Martin Petty)

U.S. CDC identifies 28 clotting cases after J&J vaccine

NEW YORK (Reuters) -The U.S. Centers for Disease Control and Prevention said on Wednesday it had identified 28 cases of serious, potentially life-threatening cases of blood clotting, among the more than 8.7 million people who had received the Johnson & Johnson COVID-19 vaccine.

The CDC said in a presentation that current evidence “suggests a plausible causal association” with the J&J vaccine and the cases of thrombosis with thrombocytopenia syndrome (TTS). TTS involves blood clots accompanied by a low level of platelets – the cells in the blood that help it to clot.

Three of the 28 have died. Previously, as of April 25, the CDC had reported 17 cases of clotting among nearly 8 million people given vaccines.

It said the events appear similar to what is being observed following administration of the AstraZeneca COVID-19 vaccine in Europe.

The syndrome does not appear to be associated with either of the COVID-19 vaccines produce by Pfizer Inc and BioNTech SA or Moderna Inc.

Most of the cases were among women aged 18 to 49, the CDC said. Rates among women aged 30-39 and 40-49 were particularly high, according to the presentation, at 12.4 cases per million and 9.4 cases per million, respectively.

Only six of the clotting events identified were in men.

(Reporting by Michael Erman; editing by John Stonestreet and Bernadette Baum)

U.S. pauses J&J COVID-19 vaccine over rare blood clots

By Manas Mishra and Michael Erman

(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The move comes a week after European regulators said they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

Johnson & Johnson’s (J&J) single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.”

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”

J&J’s shares were down 3% before the opening bell.

The U.S. move comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the J&J shot.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

The plant – meant to be one of J&J’s main U.S. manufacturing facilities – has yet to be approved by U.S. regulators to supply vaccine doses, and J&J shipments to the states were expected to fall sharply next week.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

Australia has no current plans to add J&J’s coronavirus vaccine to its immunization drive, authorities said on Tuesday, as it moves away from procuring vaccines under review for potential links to blood clots.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J., additional reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Mark Potter)

European countries may have to mix COVID-19 shots amid AstraZeneca crisis

By Matthias Blamont, Gwladys Fouche and Essi Lehto

PARIS (Reuters) – Several European countries are considering mixing up COVID-19 vaccines for citizens who received a first dose of AstraZeneca’s shot, an unprecedented move that highlights challenges for governments struggling to tame fresh rises in infections.

Vaccination programs have been upset after a small number of reports that recipients of the AstraZeneca inoculation have suffered extremely rare blood clots, leading some countries worldwide to suspend its use out of caution.

A senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday there was a link between the vaccine and rare blood clots in the brain but the possible causes were still unknown.

The EMA later said in a statement that its review of the vaccine was ongoing. It will give an update on its investigation on Wednesday afternoon.

AstraZeneca has said previously its studies have found no higher risk of clots because of the vaccine, millions of doses of which have been administered worldwide.

While many countries have resumed using the shot, some have imposed age restrictions.

In many instances, this has left officials scratching their heads over what to do for people who received a first dose of AstraZeneca but are no longer eligible under the new rules.

While the numbers are small compared with the tens of millions being inoculated across the region, the decision is significant because it has not been tested in late-stage human trials.

Any divergence to the EMA’s marketing authorization would also be considered as “off label use”, meaning it would not be approved by the regulator and leave individual countries responsible for any possible side-effects.

The EMA had no immediate comment when asked about mixing and matching vaccines and referred to the briefing later on Wednesday.

Some experts say that, because all of the vaccines target the same outer “spike” protein of the virus, they could work together to train the body to fight off the virus. There is no evidence it will be as effective.

Germany was the first European country to recommend on April 1 that people under 60 who have had a first AstraZeneca shot should receive a different product for their second dose.

Norway will decide whether to resume using AstraZeneca’s vaccine or rely on alternatives by April 15.

“The outcome is either you get one vaccine, the AstraZeneca vaccine … or you get a booster vaccine with other types of vaccines,” Sara Viksmoen Watle, a senior physician at the Norwegian Institute of Public Health, told Reuters.

Norwegian authorities are also waiting for the results of a British trial launched in February to explore mixing doses of Pfizer and AstraZeneca vaccines. The timing of the data is not known.

Britain said late last year it would allow people to be given shots of different COVID-19 vaccines on rare occasions, but it has not yet had to do so.

Finland, which resumed using the AstraZeneca vaccine from March 29, but will only give it to people aged 65 and over, said it would wait for the EMA’s conclusions before making a recommendation. It will have to start giving second doses by mid-April.

In France, where the vaccine can now only be used for those aged 55 or older, the issue affects hundreds of thousands of people.

A top health advisory body in charge of defining the use of vaccines, the Haute Autorité de la Santé (HAS), is also contemplating deploying a messenger RNA (mRNA) vaccine produced by Pfizer-BioNTech or Moderna as a second dose, according to two sources aware of the organization’s plans.

A formal decision has not been yet taken, however, as experts await more data, notably from Britain, one of the sources added. France has until early May, which marks 12 weeks after the first doses were administered.

The HAS had no comment.

Back in February, it said there was no data to assess interchangeability of AstraZeneca’s vaccine and therefore advised that those who had already received a first dose should not get a different shot when vaccinated for the second time.

“We are left guessing and that makes me and other colleagues feel very uncomfortable,” said Charlotte Senechal, a 52-year-old hospital nurse working in Strasbourg, eastern France.

India AstraZeneca shot delay could be ‘catastrophic’ for Africa: health official

ADDIS ABABA (Reuters) – India’s temporary hold on major exports of AstraZeneca’s COVID-19 shot will undermine Africa’s vaccination plans, and could have a “catastrophic” impact if extended, the head of the continent’s disease control body said on Thursday.

India decided to delay big exports of the shots made in its territory by the Serum Institute of India (SII) to make sure it could meet local demand, two sources told Reuters last week.

The hold “will definitely impact our ability to continuously vaccinate people,” the director of the Africa Centers for Disease Control and Prevention, John Nkengasong, told a news conference in Addis Ababa.

The African Union had planned to vaccinate 30-35% of the continent’s population by the end of the year he said. “If the vaccines are delayed we are unlikely to meet our target,” he added.

That AU target primarily relies on supplies from the global COVAX vaccine-sharing facility, through which 64 poorer countries including many in Africa are supposed to get doses from the SII. COVAX aims to provide enough shots for African countries to inoculate at least 20% of their populations.

“If the delay continues, I hope it’s a delay and not a ban, that would be catastrophic for meeting our vaccinations schedule,” Nkengasong said.

African countries have reported 4.25 million coronavirus infections and 112,000 related deaths, though experts have said the actual numbers could be higher.

The AU has also been negotiating with manufacturers to help member states secure the additional doses they will need to achieve 60% coverage.

On Monday, Johnson & Johnson announced it would supply the AU with up to 400 million doses of its COVID-19 vaccine. Delivery of those doses is due to begin in the third quarter of this year and will continue through 2022.

Those doses are separate from the GAVI/WHO-backed global COVAX facility.

Nkengasong said on Thursday the AU has “pivoted” towards the J&J shot in part as a result of the delay in the delivery of AstraZeneca shots, and also because it is a single-dose shot.

The J&J doses will begin to arrive in June or July, which will ease any shortage caused by the delay in the AstraZeneca doses, Nkengasong said. The gap until the arrival of the J&J doses is a concern, he added.

(Reporting by Addis Ababa newsroom; Writing by Maggie Fick; Editing by Andrew Heavens)

Immune response may be linked to AstraZeneca vaccine clot issue; death risk rising among young adults in Brazil

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.

Immune response may explain rare clots after AstraZeneca vaccine

Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca’s COVID-19 vaccine. They believe the phenomenon is similar to one that rarely occurs with a blood thinning drug called heparin, called heparin-induced thrombocytopenia (HIT). In HIT, the drug triggers the immune system to produce antibodies that activate platelets, which cause blood to clot. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger. Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported on Monday in a paper posted on Research Square ahead of peer review. Twenty individuals who received the vaccine but did not develop clots did not have these antibodies. An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly. Millions of people have received the vaccine without issues and European regulators and the World Health Organization say the benefits of the AstraZeneca shot outweigh its risks.

COVID-19 death risk rising for young adults in Brazil

Southern Brazil is seeing a sudden rise in COVID-19 deaths among young and middle-aged adults after the identification there of a concerning virus variant known as P.1, researchers said. They analyzed data from Parana – the largest state in southern Brazil – on 553,518 cases diagnosed from September 2020 through March 17, 2021. In all age groups, the proportion of patients who died either held steady or declined between September and January. Starting in February, however, fatality rates rose for almost all groups over age 20, according to a report posted on Friday on medRxiv ahead of peer review. From January to February, these rates tripled among patients aged 20 to 29, from 0.04% to 0.13%, and doubled among those aged 30 to 39, 40 to 49, and 50 to 59. “Individuals between 20 and 29 years of age whose diagnosis was made in February 2021 had an over 3-fold higher risk of death compared to those diagnosed in January 2021,” the researchers said. “Taken together, these preliminary findings suggest significant increases in case fatality rates in young and middle-aged adults after identification of a novel SARS-CoV-2 strain circulating in Brazil, and this should raise public health alarms.”

Pfizer, Moderna vaccines limit asymptomatic infections

Vaccines from Pfizer Inc and partner BioNTech SE and from Moderna Inc dramatically reduced the risk of infection by the new coronavirus within weeks after the first of two shots, according to data from a study of nearly 4,000 U.S. healthcare personnel and first responders in six states. Previous trials by the companies evaluated the vaccines’ efficacy in preventing illness from COVID-19, but would have missed infections that did not cause symptoms. In the new study, conducted from mid-December to mid-March, nearly 75% of participants had received at least one dose of vaccine, and everyone had weekly coronavirus testing for 13 consecutive weeks in order to pick up asymptomatic infections. According to a report published on Monday by the U.S. Centers for Disease Control and Prevention (CDC), the risk of infection fell by 80% two weeks or more after the first of two shots and by 90% by two weeks after the second shot. “The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s healthcare personnel, first responders, and other frontline essential workers,” CDC Director Rochelle Walensky said in a statement.

Pandemic has cut parents’ access to hospitalized children

Pediatricians have long endorsed the idea that babies and children in hospitals should not be separated from their families – a practice that in many facilities was restricted or discontinued to limit COVID-19 infections, according to new research. From mid-May through early July, researchers collected survey responses from 96 pediatric care units in 22 countries in Europe, Asia, and North America. The results – mostly from intensive care units for newborns – showed that before the pandemic, 87% of units welcomed families and 92% encouraged skin-to-skin care, according to a report published in Journal of Perinatology. After the onset of the pandemic, more than 83% of the hospital units restricted family presence, with additional restrictions placed on parental participation in their infant’s care, said study coauthor Ita Litmanovitz of Meir Medical Center in Kfar Saba, Israel. Hospitals’ decisions to limit family access did not depend on their previous rules, the availability of single-family rooms, or the virus infection rate in the hospital’s geographical area. “Restrictions during the pandemic increased separation between the infant and family,” the researchers found. These restrictions, Litmanovitz added, “go against psychological and neuroscientific evidence in support of unrestricted parental presence and ability to care for their hospitalized infants.”

(Reporting by Nancy Lapid; Editing by Bill Berkrot)

German COVID-19 cases are growing exponentially again: RKI

BERLIN (Reuters) – Coronavirus infections are rising exponentially in Germany, an expert at the Robert Koch Institute for infectious diseases said on Tuesday, putting at risk plans to lift the lockdown and revive the economy.

The number of cases per 100,000 reported on Tuesday was 83.7, up from 68 a week ago, and the RKI has said that metric could reach 200 by the middle of next month.

Germany is definitely in a third wave of the pandemic, driven by the fact it has loosened restrictions in recent weeks just as a more transmissible variant has spread, Dirk Brockmann, an epidemiologist at the RKI, told Germany’s ARD television.

“It has been totally irrational to loosen up here. It is just fueling this exponential growth,” he said.

Chancellor Angela Merkel and state leaders agreed a phased easing of curbs earlier this month along with an “emergency brake” to let authorities reimpose restrictions if case numbers rise above 100 per 100,000 on three consecutive days.

They are due to meet again on March 22 to discuss whether to allow any further relaxation of the rules.

The state government in the city of Berlin decided on Tuesday to put on hold any more easing, such as allowing restaurants or cinemas to open, the Tagesspiegel newspaper reported.

VACCINATION WOES

Germany’s decision on Monday to suspend AstraZeneca’s vaccine could delay progress in reaching herd immunity and postpone an economic recovery in the second quarter, analysts said.

The decision follows seven cases of thrombosis in Germany, including three deaths, and delivers a major setback to the country’s drive to speed up its sluggish vaccination campaign.

A planned meeting between Merkel and state leaders on Wednesday to discuss using family doctors to administer COVID-19 vaccines has been postponed until after the European Medicines Agency completes its review into the AstraZeneca shot.

AstraZeneca has said an analysis of its safety data covering reported cases from over 17 million vaccine doses given had shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or low levels of platelets.

The RKI’s Brockmann noted that 1,000 people in a million had died of COVID-19, compared to possibly 1 in a million from complications associated with the vaccine.

“In the risk groups, the risk of dying of COVID is much, much higher. That means it is probably 100,000 times more likely to die of COVID than because of an AstraZeneca vaccine,” he said.

(Reporting by Emma Thomasson and Caroline Copley, Editing by Timothy Heritage and Gareth Jones)