Archive for the ‘vaccine’ Category

CDC expert panel punts on deciding fate of J&J COVID vaccine

April 15th, 2021
Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

An advisory committee for the Centers for Disease Control and Prevention declined to vote on the fate of Johnson & Johnson’s COVID-19 vaccine Wednesday, likely leaving in place a pause on the vaccine’s use until the committee reconvenes in seven to 10 days.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, expects that the coming week or so will provide additional data and analyses on the vaccine’s potential risks. Until it has more information, ACIP opted to provide no new recommendations on the use of the vaccine.

On the table, however, was everything from recommending against use of the vaccine altogether; recommending that only certain groups receive the vaccine, such as only men or only people over a certain age; or recommending that the pause be lifted and use continue in all adults as before.

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J&J COVID vaccine use paused due to one-in-a-million complication

April 13th, 2021
Image of a woman receiving a vaccine.

Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. (credit: Tom Williams / Getty Images)

On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They've also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

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Posted in Astrazeneca, CDC, clotting, COVID-19, fda, Johnson & Johnson, medicine, science, vaccine | Comments (0)

It’s too late for vaccines to save Michigan, CDC director explains

April 12th, 2021
A woman adjusts her face mask while sitting in front of a microphone.

Enlarge / Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), adjusts her protective mask during a Senate Health, Education, Labor, and Pensions Committee hearing in Washington, DC. (credit: Getty | Bloomberg)

Highly effective COVID-19 vaccines are simply too slow to stop surges like the one underway in Michigan, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Monday.

Dr. Walensky’s explanation during the White House COVID-19 press briefing comes amid mounting requests and calls for federal authorities to flood Michigan with vaccine supply. The state has seen a 400 percent spike in cases since March 5, when state officials eased restrictions on residential gatherings and occupancy limits for bars, restaurants, venues, and stores. Since then, the highly transmissible B.1.1.7 coronavirus variant has also increased in prevalence. Now, the state’s seven-day average for new daily cases is over 7,377, and hospitals are filling up.

On March 30, when the surge was already in full swing, Michigan Gov. Gretchen Whitmer appealed to the White House for additional vaccine shipments. However, the White House declined, opting to stick to its largely population-based strategy for dolling out vaccine supply to each state and jurisdiction.

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Posted in CDC, COVID-19, Infectious disease, lockdown, Michigan, outbreak, science, social distancing, surge, vaccine, WHO | Comments (0)

Real-world data shows vaccines kicking butt—including against scary variant

April 2nd, 2021
A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021.

Enlarge / A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021. (credit: Getty | Bloomberg)

In a small trial, the Pfizer/BioNtech vaccine fully protected people from symptomatic COVID-19 caused by the worrisome B.1.351 coronavirus variant widely circulating in South Africa, the companies announced in a press release.

Though researchers will need more data to confirm the result, it is just the latest bit of positive news to come out this week about how the vaccines are performing with real-world conditions and in real-world settings.

On Monday, the Centers for Disease Control and Prevention released real-world data showing that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine were, collectively, 90 percent effective at preventing infections in fully vaccinated health care, frontline, and essential workers.

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Posted in BioNTech, coronavirus, COVID-19, Infectious disease, Pfizer, public health, SARS-CoV-2, science, vaccine, variant | Comments (0)

Factory mix-up spoils 15 million doses of J&J COVID vaccine

April 1st, 2021
A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to multiple media reports.

Johnson & Johnson had partnered with Emergent BioSolutions to manufacture the active ingredient of its vaccine. But according to two US officials who spoke with Politico, workers at the West Baltimore facility mixed up the ingredients in Johnson &Johnson’s vaccine with those for a different coronavirus vaccine. Emergent BioSolutions is also a manufacturing partner of AstraZeneca, according to the New York Times, which first reported the problem.

The mishap with Johnson & Johnson’s vaccine began before the Food and Drug Administration had authorized the facility to produce the vaccine. Now, that authorization has been delayed and shipments are stalled.

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Posted in Biden, biden administration, COVID-19, fda, Infectious disease, Johnson & Johnson, pandemic, public health, science, vaccine | Comments (0)

Trial started for vaccine against one of the scariest coronavirus variants

March 31st, 2021
Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa.

The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

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Posted in clinical trial, COVID-19, Infectious disease, moderna, NIH, public health, SARS-CoV-2, science, vaccine, variant | Comments (0)

Teens fully protected by Pfizer’s COVID-19 vaccine, company says

March 31st, 2021
Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel's Mediterranean coastal city of Tel Aviv on January 23, 2021.

Enlarge / Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel's Mediterranean coastal city of Tel Aviv on January 23, 2021. (credit: Getty | Jack Guez)

Adolescents ages 12 to 15 were completely protected from symptomatic COVID-19 after being vaccinated with the Pfizer/BioNTech mRNA vaccine in a small Phase III clinical trial, Pfizer reported in a press release Wednesday.

The company also said that the vaccine was well-tolerated in the age group, spurring only the standard side effects seen in people ages 16 to 25. The vaccine is already authorized for use in people age 16 and over.

The vaccine appeared more effective at spurring defensive immune responses in adolescents ages 12 to 15 than in the 16- to 25-year-old group, producing even higher levels of antibodies that were able to neutralize SARS-CoV-2. In a measure of neutralizing antibodies, vaccinated youths in the new trial had geometric mean titers (GMTs) of 1,239.5, compared with the GMTs of 705.1 previously seen in those ages 16 to 25, Pfizer noted.

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Posted in adolescents, antibodies, COVID-19, Infectious disease, Pfizer, public health, school, science, teens, vaccine | Comments (0)

After dramatic rebuke, AstraZeneca lowers vaccine efficacy estimate—a little

March 25th, 2021
A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021.

Enlarge / A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021. (credit: Getty | Gabriel Bouys)

Brushing aside a dramatic rebuke from government researchers and independent experts, AstraZeneca on Wednesday night announced that a new analysis found its COVID-19 vaccine to be 76 percent effective at preventing symptomatic COVID-19—down from the 79 percent efficacy estimate it announced in a press release Monday.

The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.

“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]... they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”

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Posted in Astrazeneca, clinical trial, COVID-19, fda, Infectious disease, science, vaccine | Comments (0)

Authorities raise red flags about AstraZeneca’s vaccine press release [Updated]

March 23rd, 2021
Authorities raise red flags about AstraZeneca’s vaccine press release [Updated]

Enlarge (credit: Getty| NurPhoto)

Update 4 pm EDT: The board of experts monitoring the clinical trial of AstraZeneca’s COVID-19 vaccine determined that the vaccine is actually between 69 percent and 74 percent effective at preventing symptomatic disease—not 79 percent effective, as AstraZeneca announced Monday.

According to a report by The Washington Post, the trial’s Data and Safety Monitoring Board (DSMB) had been in meetings with the company through February and March and saw data that indicated the 69-to-74 percent efficacy range. The board “strongly recommended” that the latest information be included in the company’s Monday press release.

However, the press release Monday only stated an efficacy of 79 percent and, in a second press release Tuesday, the company noted that they had used a data cut-off of February 17.

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Posted in Astrazeneca, clinical trial, COVID-19 vaccine, Infectious disease, niaid, NIH, pandemic, public health, science, vaccine | Comments (0)

AstraZeneca vaccine: 79% effective and no rare blood clots in US trial

March 22nd, 2021
Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination center in Cyprus, on March 22, 2021.

Enlarge / Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination center in Cyprus, on March 22, 2021. (credit: Getty | Etienne Torbey)

Exceeding expectations, AstraZeneca’s two-dose COVID-19 vaccine appeared highly effective against symptomatic and severe disease in a new late-stage trial conducted partly in the US. The company said it is now seeking emergency use authorization from the Food and Drug Administration. However, the vaccine may still be dogged by doubts.

The Phase III trial conducted in the US, Peru, and Chile found that the vaccine was 79 percent effective at preventing symptomatic disease, the company reported early Monday. Previous trial results suggest efficacy could be as low as 62 percent.

In the new 32,449-person trial, two-thirds of participants were dosed with the vaccine while the remaining third were given a placebo. There were five cases of severe disease in the trial, all in the placebo group. None of the vaccinated participants required hospitalization.

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Posted in Astrazeneca, blood clotting, COVID-19, CVST, efficacy, Infectious disease, public health, science, University of Oxford, vaccine | Comments (0)