J&J COVID-19 vaccine protects against Delta variant

Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months.

The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in the company’s Phase 3 ENSEMBLE study, which it used to win emergency use authorization in the U.S. That study concluded that a single dose of the vaccine led to a higher neutralizing antibody activity against the Delta variant than the Beta variant (B.1.351) that first emerged in South Africa.

Rival Moderna is developing a vaccine known as mRNA-1273.351 based on the Beta variant.

J&J also announced that its vaccine elicited a robust immune response to other common SARS-CoV-2 variants.

The company also said that its vaccine led to a strong neutralizing antibody response that…

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U.K. preps COVID-19 booster program

Photo by Frank Meriño from Pexels

The U.K. is laying the groundwork for a COVID-19 vaccine booster program starting in the fall, making it one of the first nations to do so.

The interim initiative would prioritize providing boosters to those 70 and older, other high-risk patients and frontline health workers starting in September.

Officials at the Joint Committee on Vaccination and Immunisation (JCVI) also are considering administering COVID-19 vaccines in tandem with flu vaccines. The organization doesn’t anticipate that variant-specific vaccines will be available in time for the launch of the new vaccination drive.

A second phase of the vaccine campaign would provide shots for those 50 and older, adults between the ages of 16 and 49 years who are in an at-risk group and adult household contacts of immunosuppressed individuals.

JCVI officials, however, haven’t made definitive plans yet …

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CureVac aims to rebound after announcing disappointing COVID-19 results 

Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appears to be regaining its footing.

While its stock is trading well below its Feb. 5 peak of $120.43, CVAC shares have risen 30% in the past five days to $75.95 in mid-day trading today.

The company is installing a new chief operating officer, Dr. Malte Greune, who will begin work on July 1, 2021.

Greune will work to bolster CureVac’s board and clinical and manufacturing capabilities.

Greune joins CureVac from Sanofi where he worked in an executive business development role. Gruene has held various leadership positions at pharma companies in the past decade.

Earlier this month, CureVac cofounder Ingmar Hoerr withdrew his candidacy for nomination to the company’s board. Hoerr also served as the company’s CEO from March to August 2020

CureVac has also charged another co-founder, Florian von der…

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Moderna’s COVID-19 vaccine holds its own against Delta variant in study

A small study indicated that Moderna’s messenger RNA COVID-19 vaccine was effective against the Delta variant.

Using serum samples from eight Phase 1 participants drawn one week after administering the second dose of the vaccine, the analysis found a 2.1-fold reduction in neutralizing titers against the Delta (B.1.617.2) variant relative to the ancestral strain of the virus.

The World Health Organization has urged the public  — including the fully vaccinated — to continue wearing masks and practice social distancing to reduce the spread of the Delta variant.

In related news, Moderna’s COVID-19 also won emergency use authorization in India, where scientists first identified the Delta variant.

The variant is gaining traction in the U.S. and will likely gain dominance in the coming weeks.

The vaccine appears to also offer protection against the Beta (B.1.351), Gamma (P.1), Kappa (B.1.617.1) and Eta (B.1.525) variants, although the reduction in…

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Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

British researchers report that using distinct COVID-19 vaccine types for the first and second doses appears to be effective, according to a preprint study in The Lancet.

As global health authorities seek to vaccinate as many people as possible, a potential hurdle is the need to use identical vaccines for the prime and boost stages. Using a so-called heterologous prime-boost vaccination would enable more rapid vaccination, but data about the efficacy of such a strategy have been scarce.

In the recent study, researchers randomized 830 adults 50 and older into eight groups to receive the varying combinations of the AstraZeneca and BioNTech-Pfizer vaccines.

To get a sense of the efficacy of the various combinations, the researchers used a geometric mean ratio (GMR) and geometr…

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The pandemic and cumulative disease burden are ‘existential’ threats, experts argue 

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While the pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and addressing the burden of all diseases, Yancopoulos added.

Society needs new strategies for addressing the disease burden. “By the year 2050, there will be 10 to 20 million Americans with Alzheimer’s disease with no treatment,” Yancopoulos said. While Biogen’s (NSDQ:BIIB) recently-approved aducanumab could be the first disease-modifying therapy, it remains unclear if the drug is effective.

Added to the disease burden are growing rates of obesity, diabetes, cancer and heart disease — “not to mention the potential of seeing th…

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COVID-19 vaccinations continue to decline in the U.S.

[Photo by Daniel Schludi on Unsplash]

The pace of COVID-19 vaccination in the U.S. continues to fall. Today, the U.S. administered about 600,000 COVID-19 vaccine doses, which is far fewer than two months ago.

At the mid-April peak, healthcare workers administered more than 3 million COVID-19 vaccine doses. The pace of vaccination fell steadily from that time to early June before stabilizing at around 1 million doses per day.

Complicating matters is the spread of the Delta variant (B.1.617.2), which ravaged India. The variant is now dominant in the U.K. and Europe, threatening to undermine the return to normalcy there.

According to a preprint study, the Delta variant could become dominant in the U.S. within a matter of weeks. Indeed, the variant already is the cause of almost half of COVID-19 infections in some Midwest and mountain states, said CDC Director Dr. Rochelle Walensky in a briefing on …

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No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …

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FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39. 

The conditions appear to be more common in males. 

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care. 

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

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Europe orders another 150 million doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022.

To date, the European Commission has reserved 460 million Moderna vaccine doses. 

The new deal gives the European Commission the ability to purchase new COVID-19 vaccines. 

The company is currently testing various booster options, including the use of its existing mRNA-1273 vaccine. In addition, it is developing a vaccine known as mRNA-1273.351 based on the B.1.351 variant that first emerged in South Africa. 

Interim data from a Phase 2 trial in the U.S. found that both mRNA-1273 and mRNA-1273.351 led to increased neutralizing antibody titer levels in response to the B.1.351 and P.1 variants. The mRNA-1273.351 appears to be more effective at generating an immune response to those viral lineages. The P.1 variant is also known as the “Gamma Variant.” 

Moderna also recently announced that the…

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White House allocates 55M COVID-19 vaccine doses for global distribution

[Photo by Daniel Schludi on Unsplash]The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

Get the full story at our sister site, Pharmaceutical Processing World.

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White House to allocate 55M COVID-19 vaccine doses for global distribution

The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

According to a news release, the U.S. will share 75% of the 80 million through COVAX and 25% are earmarked to help with surges around the world. The doses are slated to be allocated based on national vaccine plans, prioritizing those most at risk, including healthcare workers.

The allocation plan for the 55 million doses announced today includes 41 million to be shared through COVAX, with 14 million for Latin America and the Caribbean, with doses going to Brazil, Argentina, Brazil, Arge…

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