Johnson & Johnson stated on Thursday {that a} real-world examine confirmed its single shot COVID-19 vaccine protects in opposition to breakthrough infections and hospitalizations for as much as six months.
The examine, sponsored by the vaccine developer, was performed between Jan. 1 and Sept. 7 final yr, earlier than the Omicron variant was found.
It can also be but to be peer-reviewed.
J&J stated safety in opposition to an infection from its single dose vaccine begins to wane solely from the fourth month in comparison with the second month within the case of two-dose vaccines from rivals Pfizer Inc and BioNTech’s in addition to Moderna.
No waning of safety was discovered for ICU admissions for all of the three vaccines, J&J stated.
The firm stated the examine was carried out by accumulating claims and laboratory information masking 168 million folks.
Tag: J&J vaccine
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J&J says its single dose protects in opposition to breakthrough Covid-19 for as much as 6 months
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Coronavirus vaccine: Johnson & Johnson says second shot boosts safety
In the United States, pharmaceutical firm Johnson & Johnson mentioned a second shot of its COVID-19 vaccine given two months after the primary dose elevated efficacy to 94%. This was discovered to be the case towards reasonable to extreme programs.
A single dose has been discovered to offer 70% safety.
“A booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” mentioned Dr. Mathai Mammen, head of analysis and growth at J&J. The firm beforehand revealed information exhibiting its one-shot dose supplied safety for as much as eight months after immunisation.J&J mentioned in assertion that it ran two early research in folks beforehand given its vaccine and located {that a} second dose produced an elevated antibody response in adults from age 18 to 55. The examine’s outcomes haven’t but been peer-reviewed.
J&J’s vaccine is accredited to be used within the US, throughout Europe and there are plans for no less than 200 million doses to be shared with the UN-backed COVAX effort aimed toward distributing vaccines to poor nations. But the corporate has been affected by manufacturing issues and tens of millions of doses made at a troubled manufacturing unit in Baltimore needed to be thrown out.
The J&J vaccine has been thought-about important by quite a few well being officers to ending the pandemic as a result of it requires just one shot, however fears concerning the easier-to-spread delta coronavirus variant have prompted quite a few governments to think about the usage of booster photographs for a lot of accredited vaccines.
US President Joe Biden has been pushing for widespread booster photographs, however his vaccination marketing campaign acquired a blow final week, when a panel of specialists advising the US Food and Drug Administration, advisable towards booster photographs for youthful inhabitants teams.
The World Health Organisation has urged wealthy nations to cease administering booster doses till no less than the top of the yr, saying vaccines ought to instantly be redirected to Africa, the place fewer than 4per cent of the inhabitants is absolutely immunised.
In a paper revealed final week within the journal Lancet, high scientists from the WHO and FDA argued that the typical particular person doesn’t want a booster shot and that the authorised vaccines up to now present sturdy safety towards extreme COVID-19, hospitalisation and demise. -
Global COVID-19 wrap: Death toll crosses 1 million in Europe, says WHO; Brazilian variant detected in Kansas
A high official from the World Health Organisation stated Europe has surpassed 1 million deaths from COVID-19 and the scenario stays “serious,” with about 1.6 million new instances reported every week within the area. Addressing current issues about vaccines, Dr Hans Kluge additionally stated the chance of individuals struggling blood clots is much larger for folks with COVID-19 than individuals who obtain AstraZeneca’s coronavirus vaccine.
Speaking to reporters throughout a go to to Greece, Kluge did level to “early signs that transmission may be slowing across several countries” and cited “declining incidence” among the many oldest folks. He stated the proportion of COVID-19 deaths amongst folks over 80, who’ve been prioritized for vaccines, had dropped to almost 30% – the bottom stage within the pandemic.
“For now, the risk of suffering blood clots is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine,” he stated. “Let there be no doubt about it, the AstraZeneca vaccine is effective in reducing COVID-19 hospitalization and preventing deaths,” he added, saying WHO recommends its use for all eligible adults.Ages 16 to 29 can now get inoculated in Hong Kong
Hong Kong is increasing its vaccination drive to incorporate residents beneath 30, because it seeks to spice up the town’s slower-than-expected uptake of COVID-19 vaccines. Residents between 16 and 29 will have the ability to register to get inoculated starting April 23, in line with Secretary for the Civil Service Patrick Nip.
People queue up exterior a vaccination heart for BioNTech in Hong Kong, Tuesday, April 6, 2021. (AP Photo/Vincent Yu)
The enlargement of the vaccination program comes amid widespread hesitancy amongst residents in the direction of getting inoculated and a deepening distrust in its authorities following the deaths of a number of chronically-ill sufferers after they acquired the vaccines, in addition to reviews of residents getting the improper jab.
As of Wednesday, solely about 84 of residents within the metropolis of 75 million have acquired vaccines. Currently, Hong Kong is providing residents the selection of the Chinese-made Sinovac vaccine and the Pfizer vaccine referred to as BioNTech within the metropolis.
Serbia to fabricate Sputnik V
Serbia has introduced that it’ll start packing and later producing Russia’s Sputnik V coronavirus vaccine, which might make it the primary European state exterior Russia and Belarus to start manufacturing the jab. Serbian President Aleksandar Vucic on Thursday visited an institute within the Serbian capital Belgrade, the place he stated the Russian vaccine shall be manufactured in just a few months. He stated for now, the vaccine shall be packed in Belgrade after receiving its elements from Russia.
Although the European Union drug regulator EMA has not but authorised Sputnik V, the vaccine has been registered to be used in dozens of nations worldwide.
Torlak Institute workers stand in entrance of a picture and look ahead to the go to of Serbian President Aleksandar Vucic in Belgrade, Serbia, Thursday, April 15, 2021. (AP Photo/Darko Vojinovic)
Serbia has one of many highest inoculation charges in Europe primarily due to the federal government’s massive purchases of the Sinopharm vaccine from China and the Sputnik V vaccine. The nation is also administering the vaccines developed by PfizerBioNTech and OxfordAstraZeneca. Serbia additionally plans to begin producing the Sinopharm vaccine.France to cross 1 lakh deaths since outbreak
France is predicted Thursday to cross the grim milestone of 1,00,000 COVID-19 deaths after a 12 months of hospital tensions, on-and-off lockdowns and private loss which have left households nation-wide grieving the pandemic’s never-ending devastating toll. The nation of 67 million would be the eighth on this planet to succeed in the symbolic mark and the third in Europe after the United Kingdom and Italy.
The cumulative loss of life toll because the begin of the epidemic totaled 99,777 on Wednesday night. In current days, French well being authorities have been reporting about 300 new day by day deaths from COVID-19.
Lionel Petitpas, president of the affiliation “Victims of COVID-19” instructed the Associated Press that the variety of 1,00,000 deaths is a crucial threshold. “After months of people getting accustomed to the virus, the figure is piercing a lot of minds. It is a figure we thought would never be reached”, he stated
In this Feb. 2, 2021 file picture, a affected person affected by COVID-19 communicates with nurses by pointing to an alphabet within the ICU on the La Timone hospital in Marseille. (AP Photo/Daniel Cole, File)
French authorities spokesperson Gabriel Attal urged it’s too quickly to set a selected date to honor those that died because the nation is now combating one other fast rise in confirmed instances. “There will be an homage for sure, a national mourning for the victims of COVID-19”, Attal stated Wednesday. “That time will come.”
Experts say the 1,00,000 mark is an underestimate by not less than a number of 1000’s. Analysis of loss of life certificates reveals that some COVID-19 instances will not be reported when folks die at residence or in locations like psychiatric items and power care amenities, they stress.
France is the nation that has reported the most important variety of confirmed infections in Europe – greater than 51 million.
Denmark inspecting choices to share vaccines with poorer nations
Denmark is inspecting choices for sharing AstraZeneca’s vaccines with poorer nations after it halted use of the photographs over issues over uncommon blood clots, the World Health Organization Europe head stated on Thursday.
Denmark this week turned the primary nation to cease utilizing AstraZeneca’s COVID-19 vaccine altogether, as European officers proceed to analyze dozens of reviews of very uncommon blood clots mixed with low platelet counts which have arisen within the bloc, in addition to Britain.
The lion’s share of vaccines distributed globally, thus far, have gone to wealthier nations. “I did have this conversation with Dr. Soren Brostrom, director general of the Danish (Health Authority) yesterday and I understand that the ministry of foreign affairs of Denmark is ready to, or looking already into options, for sharing AstraZeneca vaccines with poorer countries,” WHO Europe Director Hans Kluge instructed reporters.
Denmark’s Brostrom stated his nation had come far in inoculating the aged inhabitants most liable to contracting a severe type of COVID-19, and that youthful teams have been at decrease threat of issues from the illness. That needed to be weighed in opposition to the attainable vaccine unintended effects, he stated.
Hope India will elevate export restrictions on vaccines quickly: Africa CDC director
Africa’s CDC director stated he hopes India will elevate export restrictions on COVID-19 vaccines as quickly as attainable, warning that India will not be an island. John Nkengasong spoke because the African continent of 13 billion folks doesn’t know when second doses of key vaccines will arrive and India sees a resurgence in infections. The nation is a significant vaccine producer and a crucial provider to the UN-backed COVAX initiative that goals to convey photographs to a few of the world’s poorest international locations.
“If you finish vaccinating your people before Africa or other parts of the world, you have not done yourself any justice because variants will emerge and undermine your own vaccination efforts” Nkengasong stated. He stated the uncertainty across the arrival of second doses places the African continent in a really dicey scenario.
African officers intention to vaccinate 750 million folks over the following two years however slightly below 14 million vaccine doses have been administered throughout the 54 international locations.Cases in Thailand cross 1500
Thailand’s coronavirus instances surpassed 1500 on Thursday to set one other file, sparking issues the nation’s outbreak could spiral out of hand. More than 8000 instances have been recorded since April 1 in a contemporary outbreak linked to nightclubs and bars in central Bangkok. The 1543 new instances pushes the nation’s tally to 37,543 with 97 deaths.
In this April 12, 2021, file picture, Thai employees put together a area hospital for COVID-19 sufferers in Bangkok, Thailand. (AP Photo/Somchai Chanjirakitti, File)
Dr Chawetsan Namwat from the Department of Disease Control stated the outbreak appeared to have unfold past leisure venues, with new instances now linked to seminars workplace conferences and pupil area journeys. He stated the National Infection Control Committee will meet later Thursday to debate new measures. Up to 6000 hospital beds shall be added in Bangkok.
The outbreak has added strain on the federal government to hurry up its gradual vaccination drive which has seen lower than 1 of its inhabitants inoculated.California Guv urges colleges in state to reopen
California Governor Gavin Newsom is urging all colleges within the state to reopen, saying there are not any well being limitations to getting youngsters again into lecture rooms and ending distance studying. Speaking on Wednesday, he stated, “Money is not an object now. It’s an excuse.”
His needs stay an expectation slightly than a mandate as a result of California’s decentralized schooling system lets the 1200 college districts govern themselves. Some of the most important college districts are reopening together with Los Angeles and San Diego.
Newsom stated greater than 9000 of California’s 11,000 colleges have reopened or have set plans to reopen however that’s deceptive as a result of there isn’t a uniformity in what it means for a college to be open. Some are providing one or two days of in-person instruction blended with distance studying on different days.
Hawaii lawmakers transfer to delay pay raises owing to financial harm amid pandemic
State lawmakers in Hawaii are shifting to delay pay raises scheduled for themselves, the governor and judges due to the financial harm from the coronavirus pandemic. Pay raises of 10 have been scheduled to take impact for state legislators from July 1 as beneficial by the state Salary Commission. Instead, a invoice that the House initially authorised Tuesday will defer the raises till January 2023.
Governor David Ige stated he helps suspending the pay raises. He stated he already instructed his Cabinet that he wouldn’t settle for his increase.
Albuquerque to incorporate college students in vaccination drive
The public college system in Albuquerque (New Mexico) is ramping up its efforts to get vaccines to college students. Operations chief Gabriella Duran Blakey stated 50 college students have been included in a vaccine clinic Wednesday as a part of a partnership between the varsity district and metropolis well being employees.
Next week, the varsity district stated it should use the attain of its mailing lists and social media to encourage college students to register for the vaccines being supplied in New Mexico. As quickly as subsequent Wednesday, college students might be eligible for vaccine clinics aimed particularly at them. Parents are required to attend with the intention to signal launch kinds.
Turkey data over 62,000 confirmed instances
Turkey posted one other file of 62,797 confirmed coronavirus instances on Wednesday. The ministry additionally reported 279 deaths up to now 24 hours – the best because the begin of Turkey’s outbreak.
People transfer throughout a yoga session at a yoga heart in Ankara, Turkey, late Tuesday, April 13, 2021. (AP Photo/Burhan Ozbilici)
President Recep Tayyip Erdogan on Tuesday introduced a partial lockdown throughout the first two weeks of the Muslim month of Ramadan in a bid to curb the an infection fee. He additionally warned of extra measures to come back if the variety of instances fail to lower. The measures embrace bans on inter-city journey, a return to on-line schooling, closing sports activities and leisure facilities and increasing the size of night-time curfews.
The well being ministry stated Turkey goes by way of its third peak in infections and about 85 of the instances within the nation could be traced to the variant first detected in Britain. Turkey has registered greater than 4 million instances, seventh highest on this planet. Confirmed deaths stand at greater than 34,000.
Kansas detects Covid variant from Brazil
Kansas well being officers stated the coronavirus variant from Brazil has been detected for the primary time within the state. The Kansas Department of Health and Environment’s announcement stated the P1 variant has been detected in Sedgwick County.
The company stated it’s investigating how the individual turned contaminated and whether or not others could have been uncovered. The state now has all three of probably the most broadly unfold variants.
This month, the South African variant was recognized for the primary time in Kansas in somebody from Finney County. Another variant first recognized in Britain was present in a number of Kansas counties.
Nearly 4000 folks to be revaccinated in Colorado
Colorado well being officers stated almost 4000 individuals who acquired COVID-19 vaccinations at a medical spa should be re-vaccinated as a result of they’ll’t confirm the doses have been correctly saved. The division introduced Tuesday that it had stopped vaccinations at Dr Moma Health and Wellness Clinic in Colorado Springs on Friday, after county well being officers noticed issues in vaccine storage.
The division stated the photographs given on the clinic are thought of invalid and those that acquired one shot of the Pfizer or Moderna vaccine there want to begin the two-shot vaccination course of over once more. It stated those that acquired two photographs ought to get yet another.
Hungary in talks to make up for vaccine shortfall
Hungary’s authorities is in talks with all attainable suppliers to make up for an anticipated shortfall of half 1,000,000 vaccine doses in opposition to COVID-19, Prime Minister Viktor Orban’s chief of employees stated on Thursday.
Hungary has been on the forefront of the European Union’s inoculation drive, whereas its loss of life charges have additionally been among the many highest on this planet. As of Thursday, it had vaccinated 3.1 million folks, or almost a 3rd of its inhabitants.
A person receives a shot of the Russian vaccine Sputnik V vaccine in opposition to the brand new coronavirus in Saint Margit Hospital in Budapest, Hungary, Wednesday, April 14, 2021. (Zoltan Balogh/MTI through AP)
“Inoculations require vaccines and we know that another one of the shots ordered by Brussels will be missing, the (Johnson & Johnson) vaccine will not arrive. That means half a million fewer shots,” Gergely Gulyas instructed an internet briefing.
Gulyas stated all photographs utilized in Hungary, together with these of AstraZeneca and China’s Sinopharm, have been protected and efficient. He was responding to native media reviews that some folks had nonetheless fallen sick or weren’t sufficiently immunised after being inoculated with the Chinese vaccine.
“If we can make up for the shortfall in Johnson & Johnson shots, then we can inoculate everyone (registered) by the end of May, then we will have more vaccines than the number of people registered,” Gulyas stated.
J&J clotting probe: US officers weighing subsequent steps
US well being officers are weighing the following steps as they examine a handful of surprising blood clots in ladies who acquired Johnson & Johnson’s COVID-19 vaccine. The reviews are exceedingly uncommon – thus far six instances out of greater than 7 million inoculations. And it’s not clear if they’re linked to the JJ vaccine.
European regulators have declared such blood clots a uncommon however attainable threat, with the similarly-made AstraZeneca vaccine. The Centers for Disease Control and Prevention within the US will debate in a public assembly Wednesday the right way to deal with the JJ vaccine whereas authorities examine.
“Right now, we believe these events to be extremely rare but we are also not yet certain. We have heard about all possible cases as this syndrome may not be easily recognized”, stated CDC Director Rochelle Walensky earlier than the assembly.
Malaysian well being ministry proposes ban on inter-state journey throughout Eid
Malaysia’s well being ministry has proposed retaining a ban on interstate journey all through the Eid festive season, state information company Bernama reported on Thursday, because the variety of COVID-19 infections within the nation jumped to a five-week excessive. Muslim-majority Malaysia has progressively eased motion curbs since embarking on a nationwide vaccination programme in February, although the federal government has but to determine on whether or not to permit interstate journey forward of the Eid al-Fitr pageant on May 13.
“As daily cases are still rising and not yet stable, this interstate travel needs to be postponed,” Health Minister Adham Baba was quoted as saying by Bernama.
Separately, Director-General of Health Noor Hisham Abdullah stated in a press release authorities had recognized two extra instances of a extremely contagious COVID-19 variant first found in Britain. The variant, also referred to as B.1.1.7, was present in two Malaysians who had travelled to Poland final month and examined optimistic for the coronavirus upon their return on March 30, Noor Hisham stated. -
J&J vaccine on monitor for March rollout in US, goal 1 billion doses this yr
Johnson & Johnson is on monitor to roll out its single-shot coronavirus vaccine in March, and expects to have clear information on how efficient it’s by the tip of this month or early February, the U.S. healthcare firm’s chief scientific officer stated.
Dr Paul Stoffels in an interview on Tuesday additionally stated J&J expects to satisfy its said goal of delivering 1 billion doses of its vaccine by the tip of this yr as the corporate ramps up manufacturing. Stoffels stated it was untimely to say what number of doses could be obtainable in March, presuming the corporate receives emergency authorization from the U.S. Food and Drug Administration.
The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would cut back the variety of doses available initially.“We are aiming for 1 billion doses in 2021. If it is a single dose, that means 1 billion people. But it will be in a ramp-up throughout the year,” Stoffels stated. Johnson & Johnson’s vaccine is being produced within the United States, Europe, South Africa and India with the assistance of contract producers in an effort to construct capability.
“It’s a few weeks too early to be giving final numbers on what we can launch in the first couple months,” he stated.
Expectation for top efficacy
Moncef Slaoui, chief adviser for the U.S. Operation Warp Speed vaccine growth program, stated on Wednesday the vaccine might present efficacy at or above 80%. That could be beneath the efficacy of about 95% achieved in trials of already approved vaccines from Pfizer Inc with BioNTech SE and Moderna Inc, however properly above the 50% benchmark for approval set by regulators.
It additionally has the benefit of being a single-shot vaccine, which suggests it might shield extra folks quicker, and with out the chilly storage necessities of the opposite vaccines.Stoffels stated the corporate set an efficacy goal at 60%, however internally has been taking pictures for at the least 70% to 80%. “We are very confident that the vaccine will be much higher than 60%,” he stated, including that the “aim is for the highest levels, hopefully closing in on what Moderna and Pfizer are doing.”
Interim outcomes from the corporate’s Phase I/II research, revealed on Wednesday within the New England Journal of Medicine, have helped enhance that confidence.
The research confirmed that 90% of 805 volunteers aged 18 to 55 developed protecting antibodies 29 days after a single dose, and that elevated to 100% by day 57. The research is ongoing, however the safety has lasted 71 days thus far.
Similar information in members over age 65 will probably be obtainable in late January.The research additionally evaluated the impact of two doses of the vaccine given 56 days aside, and located the booster led to greater than double the extent in neutralizing antibodies towards the virus. Side results similar to fever, muscle aches and injection web site ache, have been tolerable and resolved shortly.
Stoffels stated the interim information, mixed with monkey research revealed in the summertime exhibiting sturdy safety towards illness and transmission after a single dose, elevated his confidence within the vaccine.“The likelihood that we can now translate this into humans in our Phase III study hopefully is very high,” he stated, including, “We’ll see in a few weeks.”
Although J&J’s scientific trial protocols allowed for an early have a look at the info after 20 folks grew to become contaminated by the novel coronavirus, the corporate intends to ship information on at the least 154 confirmed circumstances – the goal wanted to completely assess the vaccine’s efficacy – when it releases outcomes.
That ought to come within the final week of January or the primary week of February, Stoffels stated. The U.S. Food and Drug Administration requires at the least two months of security information on half of the research members to make sure no surprising unwanted side effects crop up. The firm crossed that two-month threshold earlier this month.
“That point came so close to the final analysis that we decided not to do an interim analysis,” Stoffels stated.J&J plans to hunt emergency use authorization from the FDA based mostly on the research of the vaccine as a single shot, Stoffels stated.If outcomes of ongoing research counsel folks would fare higher with a second booster shot, Stoffels stated J&J would file individually for a booster dose authorization.