Tag Archives: COVID-19 shots

‘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)

COVID fight could return ‘to square one’: experts sound vaccines alarm

By Kate Kelland

LONDON (Reuters) – India’s export ban on COVID-19 shots risks dragging the battle against the pandemic “back to square one” unless wealthy nations step in to plug a gaping hole in the COVAX global vaccine-sharing scheme, health specialists said on Thursday.

COVAX, which is critical for poorer countries, relies on AstraZeneca shots made by the Serum Institute of India, the world’s biggest maker of vaccines. It was already around 100 million doses short of where it had planned to be when India halted exports a month ago amid a surge in infections there.

Rich countries with plentiful COVID-19 vaccine stocks must now share them immediately, at scale, the global experts said, otherwise the pandemic could be prolonged as the world struggles to contain a virus that is continuing to spread and mutate.

“It is a huge concern,” said Anna Marriott, health policy manager at the global charity Oxfam. She and others said it was imperative that wealthy countries and regions make good on their rhetoric and share excess vaccines now.

“The current approach that relies on a few pharma monopolies and a trickle of charity through COVAX is failing – and people are dying as a result.”

Reuters reported on Tuesday that India is extending its ban, meaning it is now unlikely to resume major exports before October.

Will Hall, global policy manager for the Wellcome global health trust, said COVAX’s heavy reliance on the Serum Institute left it vulnerable. India’s extension of its export ban made it even more crucial for rich countries to share doses via the scheme, he said, “not in six months’ time, not in a month’s time, but now”.

“We’re not going to beat this virus unless we think and act globally,” he added. “We all should be concerned about this – the more the virus continues to spread, the greater the risk of it mutating to a stage where our vaccines and treatments no longer work. If that happens we’re back to square one.”

A highly transmissible new variant of the novel coronavirus first identified in India has spread to several countries around the world.

‘VERY FEW OPTIONS’

COVAX aims to get vaccines to at least 20% of the populations of the more-than 90 low and middle-income countries signed up to receive the shots as donations. It has so far distributed about 65 million doses of mainly the AstraZeneca COVID-19 vaccine, many of them to Africa.

A spokeswoman for the GAVI vaccines alliance, which co-leads COVAX, said the facility was working hard to make up supplies.

“We’re trying to find different ways of making sure that those countries that have received the first dose are able to also receive a second dose and that vaccinations can continue,” she told Reuters. “What we need right now, to meet the immediate needs, is dose sharing.”

The United States said on Wednesday it would share a total of 20 million doses of Pfizer’s, Moderna’s and Johnson & Johnson’s vaccines by the end of June, donating a significant amount via COVAX, on top of 60 million AstraZeneca shots it had already planned to give to other countries.

EU trade commissioner Valdis Dombrovskis said this week that the bloc was working to significantly ramp up vaccine donations through COVAX in the second half of 2021. Vaccine sharing announced by EU member states has so far amounted to 11.1 million vaccines, he said, of which 9 million are being shared via COVAX.

Britain, meanwhile, will have enough surplus doses to fully vaccinate at least 50 million people in poorer countries once every adult at home has been fully vaccinated, according to analysis by UNICEF’s UK office last week.

The GAVI spokeswoman said COVAX’S reliance on the Serum Institute was based, largely, on its vast production capacity, ability to deliver at low cost and on assurances that it would be able to produce the millions of doses needed at speed.

“It always was COVAX’s plan to grow and diversify its portfolio to 10-12 vaccines but at the start of the year when approved vaccines were only slowly coming online, we had very few options available to us,” she said.

(Reporting by Kate Kelland; Additional reporting by Francesco Guarascio in Brussels and Ludwig Burger in Frankfurt; Editing by Pravin Char)

Exclusive-India’s most populous state to spend up to $1.36 billion on COVID shots amid shortage

By Krishna N. Das

NEW DELHI (Reuters) -India’s most populous state will spend up to $1.36 billion to buy COVID-19 shots and held early talks this week with companies such as Pfizer and the local partner of the maker of Russia’s Sputnik V, a state official said on Thursday.

The move by Uttar Pradesh, home to more people than Brazil, comes as many Indian states curtail vaccinations due to severe shortages amid a record surge in coronavirus infections, with India recording more than 4,000 deaths for a second straight day as its health system fails to cope.

Uttar Pradesh has also held pre-bid talks with Indian vaccine companies the Serum Institute of India (SII) – licensed to make the AstraZeneca and Novavax shots – Bharat Biotech and Cadila Healthcare as part of a global tender to buy 40 million doses over the next few months, state spokesman Navneet Sehgal told Reuters.

He said Johnson & Johnson could also confirm their participation in the tender by late Thursday via email. Sputnik V’s local distributor, Dr. Reddy’s Laboratories, has also held talks.

“Money is not an issue, we have a huge budget,” said Sehgal, a senior bureaucrat in the state of 240 million people. “We will spend up to 100 billion rupees ($1.36 billion).”

He said funds would have to be diverted from other areas to buy the vaccines.

Dr. Reddy’s and Bharat Biotech declined to comment. Pfizer, J&J, SII and Cadila did not immediately respond to requests for comment.

Uttar Pradesh has also separately ordered 10 million doses of the AstraZeneca vaccine and Bharat Biotech’s Covaxin.

“WHERE IS ‘INDIA’?”

Prime Minister Narendra Modi opened vaccinations to all adults from May 1, doubling the number of people eligible to an estimated 800 million, though domestic production will stay largely flat at about 80 million a month until July.

The result is that several states now plan to launch global supply tenders individually. Reuters earlier reported that the federal government would not import vaccines itself.

“Indian states left to compete/fight with each other in international market,” Delhi Chief Minister Arvind Kejriwal said on Twitter.

“Where is ‘India’? Portrays such a bad image of India. India, as one country, should procure vaccines on behalf of all Indian states.”

Modi’s office and the health ministry did not respond to requests for comment.

COVID-19 immunizations in the country in the past week have hit levels last seen in mid-March when India did fewer than 2 million doses a day and vaccinations were limited to only health and front-line workers.

The country has administered nearly 179 million doses, the most after China and the United States, but has given the required two doses to only 3% of its 1.35 billion people.

Vinod Kumar Paul, a top government official leading India’s response to the pandemic, told a news briefing vaccine supplies would improve significantly from August. He said more than 2 billion locally made doses may be available between August and December.

That includes 750 million doses of the AstraZeneca vaccine and 200 million of Novavax, both via SII. Others include 156 million doses of Sputnik V and shots developed by Indian companies such as Biological E.

(Reporting by Krishna N. Das; Additional reporting by Aishwarya Nair, Tanvi Mehta, Shilpa Jamkhandikar, Anuron Kumar Mitra and Sumit Khanna; Editing by Nick Macfie and Catherine Evans)

U.S. to distribute 11 million Johnson & Johnson COVID-19 shots next week – White House

By Carl O’Donnell

(Reuters) – The U.S. government will distribute 11 million doses of Johnson & Johnson’s COVID-19 vaccine next week in its continued effort to get 200 million shots in people’s arms in the first 100 days of President Joe Biden’s term, the White House said on Friday.

The United States is still on track to deliver on its goal of making shots available to all adults by the end of May, Jeff Zients, the White House’s COVID-19 response coordinator, told reporters.

Vaccine manufacturers Pfizer Inc and Moderna Inc expect to hit their target of supplying 220 million shots between them in the first quarter of 2021, he added.

J&J had said last month it would deliver 20 million doses of its single-dose inoculation in March. However, shipments were delayed because key U.S. manufacturing partners, including Catalent Inc, did not immediately receive U.S. regulatory clearance to send out doses made in their facilities.

The White House is also working to speed up administration of shots by increasing the number of active duty troops assisting with vaccinations, to more than 6,000 from 2,900, Zients said.

As of Friday, 71% of adults aged 65 and over have received at least one vaccine dose, Zients said.

Dr. Rochelle Walensky, head of the U.S. Centers for Disease Control and Prevention, said she was deeply concerned about the trajectory of COVID-19 cases in the United States. The country’s seven-day average daily case count is up 7% over last week, to 57,000 daily cases.

“We know from higher surges that if we don’t control things now, there is a real potential for the epidemic curve to soar again,” she said.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Frances Kerry)