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  • FDA restricts J&J’s Covid-19 vaccine because of blood clot danger

    Washington, May 6 (AP) US regulators have strictly restricted who can obtain Johnson & Johnson’s COVID-19 vaccine because of the ongoing danger of uncommon however critical blood clots.

    The Food and Drug Administration stated the shot ought to solely be given to adults who can not obtain a distinct vaccine or particularly request J&J’s vaccine. US authorities for months have beneficial that Americans get Pfizer or Moderna photographs as an alternative of J&J’s vaccine.

    FDA’s vaccine chief Dr. Peter Marks stated the company determined to limit the vaccine after taking one other take a look at the info on the dangers of life-threatening blood clots and concluding that they’re restricted to J&J’s vaccine.

    “If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks stated. “But we’ve been careful to say that — compared to no vaccine — this is still a better option.” The drawback happens within the first two weeks after vaccination, he added: “So if you had the vaccine six months ago, you can sleep soundly tonight knowing this isn’t an issue.” The FDA authorised J&J’s shot in February final yr for adults 18 and up.

    The vaccine was initially thought of an essential device in combating the pandemic as a result of it required just one shot. But the single-dose choice proved much less efficient than two doses of the Pfizer and Moderna vaccines.

    In December, the Centres for Disease Control and Prevention beneficial Moderna and Pfizer photographs over J&J’s due to its issues of safety.

    As of mid-March, federal scientists had recognized 60 instances of the aspect impact, together with 9 that had been deadly. That quantities to three.23 blood clot instances per 1 million J&J photographs. The drawback is extra frequent in girls underneath 50, the place the loss of life charge was roughly 1 per million photographs, in keeping with Marks.

    Marks stated the FDA spent further time analysing the issue to make sure it wasn’t related to a separate challenge, akin to girls taking contraception medicines that increase their danger of clotting.

    The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the aspect impact.

    Under the brand new FDA directions, J&J’s vaccine may nonetheless be given to individuals who had a extreme allergic response to one of many different vaccines and might’t obtain an extra dose. J&J’s shot may be an choice for individuals who refuse to obtain the mRNA vaccines from Pfizer and Moderna, and subsequently would in any other case stay unvaccinated, the company stated.

    A J&J spokesman stated in an emailed assertion: “Data continue to support a favourable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.” The clotting issues first got here up final spring, with the J&J shot within the US and with the same vaccine made by AstraZeneca that’s utilized in different nations. At that point, US regulators determined the advantages of J&J’s one-and-done vaccine outweighed what was thought of a really uncommon danger — so long as recipients had been warned.

    COVID-19 causes lethal blood clots, too. But the vaccine-linked form is totally different, believed to type due to a rogue immune response to the J&J and AstraZeneca vaccines due to how they’re made. Clots type in uncommon locations, akin to veins that drain blood from the mind, and in sufferers who additionally develop abnormally low ranges of the platelets that type clots. Symptoms of the bizarre clots embrace extreme complications per week or two after the J&J vaccination — not instantly — in addition to stomach ache and nausea.

    The New Brunswick, New Jersey-based firm introduced final month that it didn’t count on a revenue from the vaccine this yr and was suspending gross sales projections.

    The rollout of the corporate’s vaccine was harm by a collection of troubles, together with manufacturing issues at a Baltimore manufacturing facility that pressured J&J to import hundreds of thousands of doses from abroad.

    Additionally, regulators added warnings concerning the blood clots and a uncommon neurological response referred to as Guillain-Barré syndrome.

    Pfizer and Moderna have supplied the overwhelming majority of COVID-19 vaccines within the US. More than 200 million Americans have been totally vaccinated with the businesses’ two-dose photographs whereas lower than 17 million Americans acquired the J&J shot.

  • Cannabis compounds prevented Covid an infection in laboratory examine

    Cannabis compounds prevented the virus that causes Covid-19 from penetrating wholesome human cells, in accordance with a laboratory examine revealed within the Journal of Nature Products.
    The two compounds generally present in hemp — referred to as cannabigerolic acid, or CBGA, and cannabidiolic acid, or CBDA — have been recognized throughout a chemical screening effort as having potential to fight coronavirus, researchers from Oregon State University stated. In the examine, they sure to spike proteins discovered on the virus and blocked a step the pathogen makes use of to contaminate individuals.
    The researchers examined the compounds’ impact in opposition to alpha and beta variants of the virus in a laboratory. The examine didn’t contain giving the dietary supplements to individuals or evaluating an infection charges in those that use the compounds to those that don’t.

    Hemp is a supply of fiber, meals and animal feed, and extracts are generally added to cosmetics, physique lotions, dietary dietary supplements and meals.
    “These compounds can be taken orally and have a long history of safe use in humans,” stated Richard van Breemen, a researcher with Oregon State’s Global Hemp Innovation Center. “They have the potential to prevent as well as treat infection by SARS-CoV-2,” he stated in an announcement.

  • Valneva says its COVID-19 vaccine reveals comparable safety to AstraZeneca’s, fewer unwanted side effects

    Valneva SE on Monday mentioned its experimental COVID-19 vaccine demonstrated efficacy “at least as good, if not better” than AstraZeneca’s shot in a late-stage trial evaluating the 2, with considerably fewer antagonistic unwanted side effects.
    Valneva, amongst a handful of drugmakers testing their vaccines towards one already in use, is hoping its candidate, which makes use of extra conventional expertise than the mRNA vaccines, might be a extra reassuring possibility for Europeans nonetheless reluctant to be immunised.
    “The really important vaccine doses that we need to give, both nationally and internationally, are to those that have not yet been immunised,” the trial’s lead investigator Adam Finn advised reporters on a name.
    “That’s our priority.” Valneva’s VLA2001 vaccine triggered a considerably stronger immune response, he mentioned, suggesting that safety towards COVID-19 by way of antibody response can be “at least as good, if not better than the AstraZeneca vaccine.”
    Finn famous that each vaccines have been extremely efficient, notably towards extreme illness. No members have been hospitalised with COVID-19 through the trial. Adding extra reassurance, Valneva’s trial was carried out whereas the highly-transmissible Delta variant of the coronavirus, accountable for current international spikes in COVID-19 hospitalization and dying, was already circulating extensively.
    The research additionally confirmed that Valneva’s vaccine, given in two photographs 28 days aside, prompted considerably fewer antagonistic reactions, equivalent to arm ache and fever.
    Valneva’s Paris-listed shares have been up about 33% – on observe for his or her finest day ever – and have greater than doubled since January, regardless of plunging final month, when Britain scrapped a contract for round 100 million doses over considerations the vaccine may not obtain approval.
    A spokesperson for UK Prime Minister Boris Johnson mentioned the outcomes didn’t change the federal government’s determination, although Britain’s medicines watchdog would overview the outcomes as soon as it receives the complete information.
    Valneva mentioned it goals to submit the info to Britain’s regulator in November for doable approval by the tip of 2021, and hopes to win approval from the EU by the tip of March subsequent 12 months.
    The firm plans to proceed manufacturing its vaccines at a web site in Scotland.The French firm is increasing its trials to cowl each adolescents and the aged, and hopes to increase approval to those teams after it obtains approval for individuals aged 18-55.

  • ‘Cautious’ of third wave, Health Ministry sought curb on testing equipment exports

    The authorities’s transfer to limit exports of Covid-19 speedy antigen testing kits was a results of a request by the Health Ministry with a view of being “very cautious”, a senior authorities official instructed The Indian Express.
    The Directorate General of Foreign Trade (DGFT) had on Monday moved these kits to the restricted class of exports. “(It was done) because the Health Ministry wants to be very cautious,” mentioned a authorities official, who didn’t want to be quoted, indicating that the federal government needed to make sure sufficient provide of speedy testing kits within the occasion of one other spike or wave in Covid-19 infections.
    The DGFT mounted the quota of such kits that may very well be exported in July, August and September at 11.76 crore, with exporters being required to file functions to export them between August 20 and August 30. The Centre, in April 2020, restricted export of all Covid diagnostic kits and reagents, equally requiring that exporters get hold of licenses for any exports of diagnostic kits as Covid-19.
    Exports of Covid-19 RT-PCR testing kits, and their elements, RNA extraction kits and part components and viral transport media (VTM) kits are additionally restricted by DGFT, as a part of measures to make sure sufficient provides of important diagnostic and analysis instruments within the occasion of one other spike in infections. Experts have mentioned a 3rd wave could also be inevitable.

    The Indian Medical Association had in July warned of a 3rd wave and referred to as for curbs on mass gatherings. Researchers have mentioned {that a} third wave could begin as quickly as this month and peak in October.

  • WHO approves Sinovac, second Chinese-made Covid vaccine to get listed

    The World Health Organization (WHO) has accredited a Covid-19 vaccine made by Sinovac Biotech for emergency use itemizing, the second Chinese-produced shot to get its endorsement, a WHO assertion stated on Tuesday.
    WHO emergency itemizing is a sign to nationwide regulators on a product’s security and efficacy. It would additionally permit the shot to be included in COVAX, the worldwide programme to supply vaccines primarily for poor international locations, which at the moment faces main provide issues as a result of India’s suspension of vaccine exports.
    Test tubes are seen in entrance of a displayed Sinovac brand on this illustration taken, May 21, 2021. (Reuters)
    In a press release, the impartial panel of consultants stated it beneficial Sinovac’s vaccine for adults over 18, with a second dose 2-4 weeks later. There was no higher age restrict as information urged it’s prone to have a protecting impact in older individuals.