The World Health Organization on Monday asked for further data from India’s Bharat Biotech to consider the company’s request for an emergency-use listing for its COVID-19 shot, saying the WHO could not “cut corners” in making a decision.
Bharat Biotech, which developed Covaxin with an Indian state research body, started sharing data with the WHO from early July https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_29Sept2021_0.pdf. The vaccine was given emergency-use authorisation in India in January even before the completion of a late-stage trial, which later found the shot to be 78% efficacious https://www.bharatbiotech.com/images/press/covaxin-phase3-clinical-trials-interim-results.pdf.
Without a WHO nod, the two-dose Covaxin is unlikely to be accepted as a valid vaccine around the world and would complicate travel plans for tens of millions of Indians who have taken it. Covaxin accounts for 11% of the 985.5 million total doses administered in India, and has also been exported.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners,” the WHO said on Twitter https://twitter.com/WHO/status/1450069244910129154.
“Before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective.”
The WHO was expecting “one additional piece of information from the company today”, it added, without specifying.
Bharat Biotech, which has struggled to meet production timelines for Covaxin, had no immediate comment.
WHO Chief Scientist Soumya Swaminathan said https://twitter.com/doctorsoumya/status/1449756927496495112 on Sunday its technical advisory group would meet on Oct. 26 to consider the listing for Covaxin. She said the WHO’s goal was to “have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere”.
India is the world’s biggest producer of vaccines, with a capacity to make more than 3 billion COVID shots a year, mainly the AstraZeneca one.
(Reporting by Anuron Kumar Mitra in Bengaluru and Krishna N. Das in New Delhi; Editing by Shounak Dasgupta and Mark Heinrich)
'I was shocked': Mother, child mistakenly given COVID-19 vaccine instead of flu shot – Vancouver Is Awesome
WINNIPEG — A Manitoba mother says a routine appointment for her and her three-year-old to get flu shots ended in frustration and mixed messages after they were each mistakenly given an adult dose of a COVID-19 vaccine.
Jenna Bardarson is calling for policy changes at the province’s vaccination centres to make sure that doesn’t happen to another family.
The shots were administered on Nov. 24 at the Keystone Centre in Brandon.
Bardarson says that shortly after she and her daughter, Dali, got their shots, the health worker who had given them excused herself to speak with a supervisor. When the worker returned, she told them she had made a mistake and given them both the adult Pfizer-BioNTech vaccine.
“I was shocked. I didn’t know what to say. My immediate concerns were, of course, would my daughter be OK and also who could I speak to about this,” Bardarson said in online social media messages Friday to The Canadian Press.
Once she got home, Bardarson made multiple calls to different departments with the regional medical authority, hoping to speak with someone about the error and her concerns, she said.
She said no one was able to provide her with the answers or information she needed. “The conversations with various Prairie Mountain Health members have been frustrating, to say the least.”
Bardarson said she already had two doses of a COVID-19 vaccine and was due for her booster shot next month. Her daughter is too young to be eligible.
Health Canada last month approved a pediatric version of the Pfizer shot for children ages five to 11, but it has not yet approved a vaccine for those under five.
Bardarson said she and her daughter had headaches and sore arms the following day. Her daughter had no appetite and was throwing up.
Manitoba Health confirmed the mistake in a statement and said staff from Prairie Mountain have reached out to the mother to discuss what happened as well as to provide an update on an investigation.
“Patient safety is a critical aspect of all health-care services in Manitoba. We are constantly reviewing our processes to ensure that our systems support our staff in preventing errors,” it said.
“In this case … our team reviewed the existing processes to make adjustments that would help avoid a similar error from occurring in the future.”
Bardarson said the health region has not provided her with updated information on the investigation and would not discuss any consequences the health worker may have faced.
Manitoba Health said no further action would be taken against the worker, because she immediately recognized the error and told a supervisor.
For Bardarson, that’s not enough.
“I by no means want her fired; however, there should be some sort of measures in place for harm reduction.”
Bardarson suggested taking away the worker’s injection privileges or enhanced supervision during vaccinations.
She said she would also like to see areas at vaccination centres separated by vaccine types, instead of having different vaccines offered in the same booth.
Manitoba Health could not say if others have been given a COVID-19 vaccine by mistake, but acknowledged that medication errors, although rare, do occur. It added that Bardarson was provided with information about the risks of the COVID-19 vaccine, which in this case it says are low.
Health Canada said it is not in charge of immunization monitoring and could not comment on whether similar mistakes have occurred in other parts of the country.
This report by The Canadian Press was first published Dec. 3, 2021.
The story was produced with the financial assistance of the Facebook and Canadian Press News Fellowship.
Brittany Hobson, The Canadian Press
Vaccine makers could make Omicron-specific booster, says Fauci
COVID-19 vaccine makers have contingency plans to deal with the Omicron variant that include a combination vaccine against the original version and the variant as well as a variant-specific booster dose, a top U.S. health official said on Friday.
The U.S. government is working with Moderna, Pfizer, and J&J on multiple contingency plans, infectious disease expert Anthony Fauci told reporters at a White House briefing.
“One is to rev up the production of the vaccines that they already have. The next is to make, for example, a bivalent, where you have the vaccine against both the ancestral strain and the new variant, and the other is to make a variant-specific boost,” said Fauci.
“They are now assuming they may have to do that and are being prepared for that,” he added.
Data from a National Institutes of Health study strongly suggest that existing boosters provide cross protection against a number of variants, including Omicron, Fauci said.
“Although we haven’t proven it yet, there’s every reason to believe that if you get vaccinated and boosted that you would have at least some degree of cross protection, very likely against severe disease, even against the Omicron variant.”
The U.S. Centers for Disease Control and Prevention is working with local authorities to investigate suspect cases of the Omicron variant in states other than those where cases have already been reported, Director Rochelle Walensky said at the briefing.
There have been cases of Omicron detected in about 40 countries, she said, but the Delta variant remains the dominant strain in the United States.
“I know that the news is focused on Omicron. But we should remember that 99.9% of cases in the country right now are from the Delta variant. Delta continues to drive cases across the country, especially in those who are unvaccinated,” she said.
(Reporting by Ahmed Aboulenein and Jeff Mason; Additional reporting by Doina Chiacu; Editing by Rosalba O’Brien and Dan Grebler)
FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly
The U.S. health regulator has added its strictest warning to the labels of drugs from Pfizer, Eli Lilly and AbbVie belonging to a class of anti-inflammatory treatments called JAK inhibitors, citing risk of serious health issues and death in patients 50 and over, the drugmakers said on Friday.
The addition of the warning on the labels follows the agency’s review of Pfizer’s Xeljanz after initial results from a February trial showed an increased risk of serious heart-related problems and cancer in some patients being treated with the drug.
Xeljanz, which brought in worldwide sales of $2.44 billion for Pfizer in 2020, is approved in the United States for the treatment of conditions including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis – an inflammatory bowel disease.
AbbVie’s rheumatoid arthritis drug Rinvoq and Pfizer’s Xeljanz are now recommended for use only in patients, who have had inadequate response or intolerance to one or more TNF blockers, which are another class of drugs used against inflammatory conditions.
The Food and Drug Administration’s boxed warnings on the labels of Rinvoq , Xeljanz and Lilly’s Olumiant flags the risk of cardiovascular death and stroke in high-risk patients who are aged 50 and above, and are current or past smokers.
Additional information about the risk of some types of cancer and death was also added to their labels.
The marketing applications for Rinvoq’s expanded use in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis remain under review by the FDA, AbbVie said.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D’Silva and Krishna Chandra Eluri)
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