pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Vaccination Vaccine Trials Immune Response 98

BioPharma Reporter

SEPTEMBER 14, 2021

Johnson & Johnson says data published in The Lancet on its Ebola vaccine regimen shows it has a robust and durable immune response in adults and children.

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Vaccination Vaccine Immune Response Regulation 93

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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Vaccination Vaccine Immune Response Trials 105

pharmaphorum

NOVEMBER 26, 2020

AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.

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Vaccination Vaccine Trials Immune Response 98

pharmaphorum

APRIL 16, 2021

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. The study follows investigations into potential links with the AstraZeneca vaccine and rare blood clots. But the researchers concluded they are still rarer after a vaccine.

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Vaccination Vaccine Immune Response Research 105

pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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Vaccination Vaccine Recombinant DNA Technology Trials 89

pharmaphorum

SEPTEMBER 24, 2020

The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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Vaccination Vaccine Trials Immune Response 98

pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.

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Vaccination Vaccine Immune Response Regulation 90

pharmaphorum

NOVEMBER 19, 2020

The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

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Immune Response Vaccination Vaccine Regulation 105

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

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Protein Vaccination Vaccine Immune Response 126

Pharmaceutical Technology

APRIL 11, 2023

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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FDA Approval Drugs Immune Response Manufacturing 130

pharmaphorum

DECEMBER 22, 2020

BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the south east of England, although further studies will be needed. Sahin said: “We don’t know at the moment if our vaccine is also able to provide protection against this new variant.

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Vaccination Vaccine Protein Immune Response 81

XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

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Vaccination Vaccine Protein Immune Response 105

XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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Vaccination Vaccine Development Clinical Trials 96

STAT News

OCTOBER 19, 2022

… Moderna disclosed that its Covid-19 vaccine booster targeting the BA.1 1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months , Reuters notes. Omicron-tailored 5 targeted vaccine later this year. 5 subvariants of Omicron.

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Immune Response Scientist Vaccination Vaccine 98

pharmaphorum

FEBRUARY 24, 2021

The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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Vaccination Vaccine Immune Response Regulation 59

pharmaphorum

DECEMBER 11, 2020

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. AZ to combine vaccine with Russian rival.

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Immune Response Trials Vaccination Vaccine 72

pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. Mixing of the two mRNA vaccines is permitted for the third shot if the original vaccine received by a person is not available, according to the agency.

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FDA Approval Vaccination Vaccine Antibody 105

pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. It will also cover some infectious disease targets.

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Clinical Trials Clinical Trials Trials Vaccination 111

pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. .

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Vaccination Vaccine Antibody Immune Response 98

XTalks

JULY 26, 2021

The Centers for Disease Control and Prevention (CDC) has endorsed the J&J/Janssen COVID-19 vaccine, stating that the benefits of the vaccine still outweigh any potential risks. million administered vaccine doses have been reported among those who received the J&J COVID-19 vaccine.

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Vaccination Vaccine Immune Response Antibody 98

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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Vaccination Vaccine Trials Immune Response 52

pharmaphorum

SEPTEMBER 29, 2020

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline. Inovio’s vaccine takes the form of a DNA plasmid coding for the full length of the spike or ‘s’ glycoprotein antigen of SARS-CoV-2, the vaccine that causes COVID-19.

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Vaccination Vaccine Trials DNA 52

pharmaphorum

OCTOBER 6, 2020

The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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Vaccination Vaccine RNA Immune Response 59

pharmaphorum

JUNE 14, 2021

The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. billion doses are due to go to the COVAX programme, which distributes vaccines to poorer countries.

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Vaccination Vaccine Immune Response Protein 84

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

FEBRUARY 18, 2021

The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Mutations may alter neutralisation by affecting spike function rather than antigen response and its also unclear from this study how the T-cell response is affected.

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Immune Response Genetic Engineering Vaccination Vaccine 52

Find Me Cure

APRIL 23, 2020

For Covid-19 the herd immunity threshold is 70% but this is only a rough estimate based on the current numbers we’re seeing. . Firstly, even though scientists are busy developing a vaccine, one is not expected earlier than 2021. Thus, herd immunity wouldn’t work in this scenario.

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Immune Response Antibody Scientist Development 117

The Pharma Data

AUGUST 28, 2020

The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work. This could include pharmacists, who already deliver flu vaccines, midwives and physiotherapists. But a vaccine is not expected to be ready before Christmas. Source link.

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Vaccination Vaccine Immune Response Medicine 52

The Pharma Data

JANUARY 21, 2021

Because the new COVID-19 vaccines should still work on these viral interlopers. Luckily, the new variants still rely on the coronavirus’ “spike protein” to infect cells, and the two COVID vaccines now on the U.S. FRIDAY, Jan. “The spike is really critical. “That process is done so efficiently by the [U.S.

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Vaccination Vaccine Protein Immune Response 52

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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Vaccination Vaccine Protein Antibody 52

The Pharma Data

DECEMBER 11, 2020

11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. regulators. A recent COVID-19 infection could put a person a bit farther back in line for the vaccine, however.

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Vaccination Vaccine Immune Response Trials 52

The Pharma Data

SEPTEMBER 3, 2020

Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies. Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies.

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Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

VirTrial

OCTOBER 25, 2023

Vaccine studies can be large, multinational endeavors with sensitive timeframes, extended participation follow-up periods, multiphase designs, and critical data management needs. In recent years, Signant has been a part of more than 95 vaccine studies involving 140,000+ patients in more than 30 countries.

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Vaccination Vaccine Development Clinical Trials 52

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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Immune Response Trials Drugs Containment 72