Tag Archives: Moderna

Factbox: Countries respond to heart inflammation risk from mRNA shots

(Reuters) – Some countries have halted altogether or are giving only one dose of COVID shots based on so-called mRNA technology to teens following reports of possible rare cardiovascular side effects.

Europe’s drug regulator said in July it had found a possible link between a very rare inflammatory heart condition and COVID-19 vaccines from Pfizer/BioNTech and Moderna.

However, the benefits of mRNA shots in preventing COVID-19 continue to outweigh the risks, European and U.S. regulators and the World Health Organization have said.

Here are some of the steps some countries are taking:

CANADA

The Public Health Agency of Canada said data suggested that reported cases of rare heart inflammation were higher after Moderna’s COVID-19 vaccine compared with the Pfizer/BioNTech shots.

SWEDEN

Sweden paused the use of Moderna’s COVID-19 vaccine for younger groups, citing data from a yet unpublished Nordic study.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated.

DENMARK

The Danish Health Agency said on Friday that it was continuing to offer Moderna’s COVID-19 vaccine to under-18s, and that a statement on Wednesday suggesting a suspension had in fact been a miscommunication.

FINLAND

Finland paused the use of Moderna’s vaccines for younger people and instead would give Pfizer’s vaccine to men born in 1991 and later. It offers shots to those aged 12 and over.

HONG KONG

A panel of health experts advising the Hong Kong government has recommended in September children aged 12-17 should get only one dose of BioNTech’s COVID-19 vaccine after reports of heart inflammation as a side effect.

NORWAY

Norway is giving one dose of Pfizer/BioNTech vaccine to children aged 12-15.

UNITED KINGDOM

Britain has been offering all 12-15-year-olds a first a shot of the Pfizer/BioNTech vaccine. Second doses would not be offered to the age group until at least spring when there may be more data from around the world.

(Compiled by Antonis Triantafyllou; Editing by Anna Pruchnicka and Tomasz Janowski)

Factbox-Latest on the worldwide spread of the coronavirus

(Reuters) – Japan will lift a state of emergency in all regions on Thursday as the number of new cases falls, while India reported the smallest daily rise in COVID-19 deaths since mid-March.

DEATHS AND INFECTIONS

EUROPE

* Sweden will offer additional groups, including people aged 80 and above, to top up their COVID-19 vaccinations with a third dose, the Nordic country’s health minister said.

* Italy’s health ministry said on Tuesday it had given the go-ahead for travel to six non-European tourist spots without the need for quarantine as a COVID-19 precaution either on arrival or return.

AMERICAS

* New York hospitals began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services.

* Brazil will provide COVID-19 vaccine booster shots to all its people over 60-years-old, Health Minister Marcelo Queiroga said.

* A Brazilian hospital chain tested unproven drugs on elderly COVID-19 patients without their knowledge as part of an effort to validate President Jair Bolsonaro’s preferred ‘miracle cure,’ a lawyer for whistleblowing doctors told senators on Tuesday.

* Authorities in Costa Rica said on Tuesday all state workers will need to be vaccinated against COVID-19, making it one of the first countries in Latin America to impose a coronavirus vaccination mandate.

ASIA-PACIFIC

* China administered about 3.0 million doses of COVID-19 vaccines on Sept. 27, bringing total doses to 2.203 billion, data from the National Health Commission showed.

* India’s drug regulator has allowed vaccine maker Serum Institute to enroll kids aged 7-11 years for its trial of U.S. drugmaker Novavax’s COVID-19 vaccine.

* Sydney residents who are not vaccinated against COVID-19 risk being barred from various social activities even when they are freed from stay-at-home orders in December.

MIDDLE EAST AND AFRICA

* Egypt is now providing immediate COVID-19 vaccinations at youth centers across the country without prior online registration, a step aimed at encouraging vaccinations and relieving pressure on hospitals and health units amid a fourth wave of infections.

* Algeria will start production of COVID-19 vaccine Sinovac in partnership with China on Wednesday with the aim of meeting domestic demand and exporting the surplus, the prime minister’s office said on Tuesday.

MEDICAL DEVELOPMENTS

* Pfizer and BioNTech have submitted initial trial data for their COVID-19 vaccine in 5-11 year old’s and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.

* Sanofi is dropping plans for its own mRNA-based COVID-19 vaccine because of the dominance achieved by BioNTech-Pfizer and Moderna in using the technology to fight the pandemic, the company said.

* As Merck & Co and Pfizer prepare to report clinical trial results for experimental COVID-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own.

ECONOMIC IMPACT

* Global shares fell for a third successive day on Tuesday, with tech stocks plummeting, as anxiety over when central banks might raise interest rates led to rising bond yields on both sides of the Atlantic.

* Profits at China’s industrial firms grew at a weaker pace in August from a year earlier, slowing for a sixth consecutive month, as manufacturers struggled with high commodity prices, COVID-19 outbreaks and shortages of some key components.

* The East Asia and Pacific region’s recovery has been undermined by the spread of the Delta variant, which is likely slowing economic growth and increasing inequality in the region, the World Bank said.

(Compiled by Ramakrishnan M., Vinay Dwivedi and Juliette Portala; Edited by Arun Koyyur and Shounak Dasgupta)

Antibody levels higher after Moderna shot; Lilly arthritis drug used with steroid cuts death risk

By Nancy Lapid

(Reuters) – The following 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.

Antibody levels are higher after Moderna vaccine

The mRNA vaccine from Moderna Inc induces higher levels of antibodies against the coronavirus that causes COVID-19 than the similar vaccine from Pfizer Inc and partner BioNTech SE, Belgian researchers have found, although what this means for their efficacy is not clear. Soon after receiving their second shot, the 688 healthcare workers who got Moderna’s vaccine had antibody levels roughly twice as high as the 959 who received the Pfizer/BioNTech product, regardless of their ages, doctors at a Belgian medical center reported. This held true even after accounting for individual risk factors, and regardless of whether participants had previously been infected with the virus, the researchers reported on Monday in JAMA. Antibodies are just one component of the immune system’s defenses, however. The study cannot determine whether one vaccine is more effective at preventing infection or illness, or whether the antibodies induced stay longer in the blood before disappearing. Those questions, and others, require further investigation, the researchers said.

Arthritis drug adds to benefit of steroids in severe illness

Hospitalized COVID-19 patients died less often if they received Eli Lilly and Co’s rheumatoid arthritis drug baricitinib along with the other treatments their doctors had prescribed, according to a study published on Wednesday in The Lancet Respiratory Medicine. The randomized trial involved 1,525 seriously ill patients, all of whom needed extra oxygen to help with breathing. More than 90% were already receiving dexamethasone, a cheap generic steroid known to improve survival of critically ill COVID-19 patients. While baricitinib, sold under the brand name Olumiant, did not appear to keep patients from getting sicker, it did reduce their risk of dying. The 28-day and 60-day death rates were 5% lower among patients randomly assigned to receive baricitinib instead of a placebo. Baricitinib is already approved in the United States for use in hospitalized COVID-19 patients in combination with Gilead Science’s antiviral drug remdesivir. The two drugs together appear to have more benefit than remdesivir alone. In the new study, more than 80% of participants were not receiving remdesivir, suggesting that baricitinib also “has synergistic effects with other standard-of-care treatments,” including dexamethasone, researchers said.

Vaccine poses low risk for adults with high-risk allergies

Highly allergic adults can safely receive the COVID-19 vaccine from Pfizer/BioNTech, a new study suggests. Among the 8,102 patients with allergies in the Israeli study, 95% received the shots in routine settings because their risk of a severe allergic reaction to the vaccine was low, and no such reactions were reported. The remaining 429 patients, who were considered to be highly allergic, received the vaccines under careful supervision and were observed for two hours afterward. Nine had allergic reactions, including three who showed signs of potentially life-threatening anaphylaxis. All responded to treatment with epinephrine and no one had to be hospitalized, according to a report published on Tuesday in JAMA Network Open published with the study said lessons from this study of allergic reactions to the Pfizer vaccine are likely “generalizable to the Moderna” shot as well.

(Reporting by Nancy Lapid; Editing by Bill Berkrot)

‘Likely link’ between rare heart inflammation and Pfizer, Moderna vaccines -CDC advisers

By Michael Erman and Manojna Maddipatla

(Reuters) -Rare cases of heart inflammation in adolescents and young adults is likely linked to vaccination with the Pfizer/BioNTech and Moderna COVID-19 shots, a group of doctors advising the U.S. Centers for Disease Control and Prevention (CDC) said in a presentation released on Wednesday.

The COVID-19 Vaccine Safety Technical (VaST) Work Group said in their report that the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males.

The CDC said in another report that the patients with heart inflammation following vaccination generally recover from the symptoms and do well.

The Advisory Committee on Immunization Practices (ACIP) is meeting on Wednesday to assess the possibility of a link between the heart condition and the mRNA vaccines. VaST is a sub-group of ACIP.

The CDC has been investigating cases of heart inflammation mainly in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer’s COVID-19 vaccine.

The CDC earlier this month said it was still evaluating the risk from the condition and did not confirm a causal relationship between the vaccines and the heart issue.

The agency, however, said a higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 shots, with more than half the cases reported in people between the ages of 12 and 24.

Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said in a presentation that data from one of the agency’s safety monitoring systems – Vaccine Safety Datalink (VSD) – suggests a rate of 12.6 cases per million in the three weeks after the second shot in 12- to 39-year-olds.

ACIP will discuss the benefits of the mRNA vaccines versus the potential risk to adolescents and young adults from the heart condition, according to the agency’s agenda.

Although health officials in Israel have determined that there is likely a link between vaccination and the heart inflammation, concerns about the more infectious Delta coronavirus variant have prompted the country to urge 12-to 15-year old’s get vaccinated.

Pfizer, whose vaccine has been authorized for use in Americans as young as 12, previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population.

Moderna had said it could not identify a causal association with the heart inflammation cases and its vaccine.

Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.

(Reporting by Michael Erman in New Jersey and Manojna Maddipatla in Bengaluru; Editing by Bill Berkrot)

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)

India, big vaccine exporter, now vaccine exporter as COVID-19 cases soar

By Alasdair Pal and Krishna N. Das

NEW DELHI (Reuters) -India on Tuesday said it will fast-track emergency approvals for COVID-19 vaccines authorized by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.

The move, which will exempt companies from carrying out local safety trials for their vaccines, follows the world’s biggest surge in cases in the country this month.

Since April 2, India has reported the highest daily tallies of infections. It reported 161,736 cases on Tuesday, taking the total to 13.7 million, while deaths rose by 879 to 171,058.

On Tuesday, India’s richest state Maharashtra, which accounts for about a quarter of the country’s cases, said it would impose stringent restrictions from Wednesday to try to contain the spread.

India has the biggest global vaccine manufacturing capacity and had exported tens of millions of doses before its own demand skyrocketed and led to a shortage in some states.

Dozens of poor countries have relied on Indian exports to run their inoculation drives.

The health ministry said vaccines authorized by the World Health Organization or authorities in the United States, Europe, Britain and Japan could be granted emergency use approval in India.

“If any of these regulators have approved a vaccine, the vaccine is now ready to be brought into the country for use, manufacture and fill-and-finish,” Vinod Kumar Paul, a senior government health official, told a news conference.

“We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others … to be ready to come to India as early as possible.”

Pfizer said it would work towards bringing its vaccine to India after withdrawing its application in February.

U.S. federal health agencies on Tuesday recommended pausing use of the J&J shot after six women under age 50 developed rare blood clots after receiving it.

India has administered more than 108 million vaccine doses, sold more than 54.6 million vaccine doses abroad and gifted more than 10 million to partner countries.

It is currently using the AstraZeneca shot and a homegrown vaccine for its own immunization drive, and this week approved Russia’s Sputnik V shot for emergency use.

RALLIES, RELIGIOUS GATHERINGS

The jump in India’s infections, for which Health Minister Harsh Vardhan acknowledged widespread failure to heed curbs on movement and social interaction, has prompted calls for the government to cancel huge public events.

Still, hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of the weeks-long Kumbh Mela – or pitcher festival.

Nearly a million bathed in the Ganges on Monday in the belief that its waters would wash away their sins. More than 100 tested positive for COVID-19 in random testing of around 18,000 attendees, media said.

Similar concerns of a spike in cases were sparked by mass election rallies by Prime Minister Narendra Modi’s party and opposition groups during polls in four states and one federally run region.

At one rally in the eastern state of West Bengal, a key political prize, Home Minister Amit Shah posted Twitter pictures of meetings with crowds of supporters while unmasked.

DEADLY SPREAD

The second wave of infections, which began in India’s major cities, is increasingly spreading into the hinterland, where healthcare facilities are often rudimentary.

In Raipur, the capital of Chhattisgarh state known for its large tribal population, the main government hospital’s morgue was struggling to keep up, said joint director Dr Vineet Jain.

“All oxygenated and ICU beds are full in our set-up,” he told Reuters.

“Around 50 dead bodies are laying, we have a shortage of space. Some private hospitals do not have space to keep the dead bodies so they also send the bodies to us.”

India is currently reporting around double the daily cases of the United States and Brazil, the two other worst affected countries, though its daily death toll is lower.

India’s total infections rank after only the United States, having overtaken Brazil on Monday.

(Reporting by Krishna N. Das and Alasdair Pal in New Delhi and Jatindra Dash in Bhubaneswar; Editing by Nick Macfie, Ana Nicolaci da Costa and John Stonestreet)

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)

U.S. administers 168.6 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 168,592,075 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 219,194,215 doses, the U.S. Centers for Disease Control and Prevention said.

The tally is for Moderna, Pfizer/BioNTech, and Johnson & Johnson’s vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

According to the tally posted on April 5, the agency had administered 167,187,795 doses of the vaccines, and distributed 207,891,395 doses.

The agency said 108,301,234 people had received at least one dose while 63,016,976 people are fully vaccinated as of Tuesday.

A total of 7,748,620 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Manojna Maddipatla in Bengaluru)

Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use, -U.S. study

By Ankur Banerjee and Vishwadha Chander

(Reuters) – COVID-19 vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc reduced the risk of infection by 80% two weeks or more after the first of two shots, according to data from a real-world U.S. study released on Monday.

The risk of infection fell 90% by two weeks after the second shot, the study of just under 4,000 vaccinated U.S. healthcare personnel and first responders found.

The study by the U.S. Centers for Disease Control and Prevention (CDC) evaluated the vaccines’ ability to protect against infection, including infections that did not cause symptoms. Previous clinical trials by the companies evaluated their vaccine’s efficacy in preventing illness from COVID-19.

The findings from of the real-world use of these messenger RNA (mRNA) vaccines confirm the efficacy demonstrated in the large controlled clinical trials conducted before they received emergency use authorizations from the U.S. Food and Drug Administration.

The study looked at the effectiveness of the mRNA vaccines among 3,950 participants in six states over a 13-week period from Dec. 14, 2020 to March 13, 2021.

“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.

The new mRNA technology is a synthetic form of a natural chemical messenger being used to instruct cells to make proteins that mirror part of the novel coronavirus. That teaches the immune system to recognize and attack the actual virus.

The CDC study comes weeks after real-world data from Israel suggested that the Pfizer/BioNTech vaccine was 94% effective in preventing asymptomatic infections.

Some countries, including Britain and Canada, are allowing extended gaps between doses that differ from how the vaccines were tested in clinical trials in order to alleviate supply constraints. In the trials, there was a three-week gap between Pfizer shots and four weeks for the Moderna vaccine.

In Britain, authorities said in January that data supported its decision to move to 12 weeks between the first and second Pfizer/BioNtech shots. Pfizer and its German partner have warned that they had no evidence to prove that.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Peter Henderson and Bill Berkrot)

Moderna plans trial of altered COVID-19 vaccine booster to address South Africa variant

(Reuters) – Moderna said on Monday it plans to start clinical trials of an altered booster version of its COVID-19 vaccine aimed at the South African variant after tests showed its authorized vaccine may produce a diminished antibody response.

It will also test an additional booster shot of its authorized vaccine in trials to see if it boosts antibody reaction against the South Africa variant. The current regimen is for two shots four weeks apart.

The company said in a press release that it was being cautious and that the two-dose regimen of the vaccine was still expected to be protective against the South African and other variants detected to date.

The company said the vaccine did not see any impact from the U.K. variant – which has been shown to be more transmissible – in the tests.

The company said it plans to publish data from its tests against the South African and U.K. variants on the website bioRxiv.

(Reporting by Manas Mishra in Bengaluru and Caroline Humer in New York; Editing by Maju Samuel and Saumyadeb Chakrabarty)