PLOS: DNA Science

DECEMBER 21, 2023

million one-and-done gene therapy in 2021, by eight months of age, could only hold his head up for a few seconds. My third COVID article was perhaps the most cited, from February 20 of that first year, COVID-19-vaccine-will-close-in-on-the-spikes. ” My younger sister and I straddled the introduction of a vaccine against measles.

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Drug Target Review

JULY 19, 2023

The mad scramble 1 for -80°C freezers during the COVID-19 pandemic is a vivid illustration that we remain unprepared to harness the global potential of vaccine therapeutics. 2 However, it is not just problematic cold chains that limit access to life-saving vaccines.

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The Pharma Data

JANUARY 11, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product. 18, 2020 ). It has already received $2.8

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The Pharma Data

JANUARY 29, 2021

French vaccine company Valneva said it has begun production of its investigational COVID-19 vaccine, which is now in a phase 1/2 clinical trial in the UK. Valneva also plans to test the vaccine in more than 4,000 patients in additional trials. Martin Berman-Gorvine. Source link.

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Drug Discovery Today

APRIL 15, 2021

First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021

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Eye on FDA

JANUARY 5, 2022

But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice? ), there were fewer 2021 meetings held to consider new drug applications than in years gone by.

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The Pharma Data

JANUARY 10, 2021

Multiple COVID-19 vaccine developers are expected to file for regulatory approval in the coming months as the global pandemic continues its relentless advance. The European Commission, which will receive the same data, is not expected to approve the AZ/Oxford University vaccine until February or later ( DID , Dec. and EU approvals.

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The Pharma Data

DECEMBER 18, 2020

COVAX now has agreements in place to access nearly two billion doses of several promising vaccine candidates, and laid the groundwork for further doses to be secured through contributions from donors. billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

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Drug Discovery Today

MAY 18, 2020

A ‘virtual VMIC’ will be created to rapidly expand the UK capacity to manufacture a COVID-19 vaccine. VMIC’s permanent facility, currently being built, will be fast tracked to come online in Summer 2021 – a year ahead of schedule.

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The Pharma Data

JANUARY 27, 2021

Government to Increase Vaccine Deliveries to States. In response to COVID-19 vaccine shortages, the U.S. government will increase vaccine deliveries to states by 16% over the next three weeks and plans to have enough to vaccinate 300 million people by the end of summer or early fall, President Joe Biden said Tuesday.

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Agency IQ

MARCH 7, 2024

Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season.

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The Pharma Data

JANUARY 7, 2021

Below are newsworthy items compiled by the HealthDay staff: NFL Urges Teams to Offer Stadiums as Vaccination Centers. The NFL is asking teams to use their stadiums as places people can go to get vaccinated for COVID-19, CBS News reported Wednesday. ” Using arenas for vaccinations isn’t a new idea. . Source link.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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The Pharma Data

SEPTEMBER 30, 2021

As one among the leading global vaccines companies, we still bring options which help protect people’s health round the world,” said Michael Greenberg, MD, MPH, Medical Head, Sanofi Pasteur North America. “As 4,5 The CDC recommends a primary dose of the MenACWY vaccine at 11-12 years old and a second dose at 16 years old. In the U.S.,

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The Pharma Data

JANUARY 25, 2021

Severe Allergic Reactions to Moderna COVID-19 Vaccine Rare: CDC. Only 10 people in the entire United States have had severe allergic reactions to Moderna’s COVID-19 vaccine, out of more than 4 million who’ve received the first dose, a new government report shows. minutes after vaccination. © 2021 HealthDay. .

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The Pharma Data

JANUARY 21, 2021

NYC May Run Out of COVID-19 Vaccines. New York City’s COVID-19 vaccination rate has outpaced its supply of vaccine, and the city could run out of doses in the next few days, Mayor Bill de Blasio said Tuesday. The mayor asked the federal government to send more vaccine as soon as possible, CBS News reported.

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The Pharma Data

JANUARY 4, 2021

” Britain to Try Mix-and-Match COVID-19 Vaccinations. If a second dose of the first COVID-19 vaccine isn’t available or the maker isn’t known, then another vaccine may be used, new British guidelines say, The New York Times reported Sunday. Britain has green-lighted vaccines from Pfizer and AstraZeneca.

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The Pharma Data

JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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The Pharma Data

JANUARY 20, 2021

based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus. Emeryville, Calif.-based

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The Pharma Data

NOVEMBER 17, 2020

Gavi, the Vaccine Alliance welcomes latest pledges in support of the Gavi COVAX AMC , a financing mechanism that will support 92 low- and middle-income economies’ access to safe and effective COVID-19 vaccines. Nine candidate vaccines are currently being supported by CEPI; eight of which are currently in clinical trials.

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The Pharma Data

JANUARY 19, 2021

California is placing its hopes on mass vaccinations to reduce the number of infections but there have been snags in the immunization drive.the AP reported. Erica Pan, the state epidemiologist, urged that providers stop using one lot of a Moderna vaccine because some people needed medical treatment for possible severe allergic reactions.

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The Pharma Data

JANUARY 22, 2021

Florida Targets ‘ Vaccine Tourism’ Florida officials are trying to put a stop to “vaccine tourism,” in which people from outside the state travel there to get vaccinated. million people who’ve been vaccinated in the state, 39,000 reside outside of Florida, state health department data show.

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The Pharma Data

JANUARY 15, 2021

” The British scientists plan to follow people in the study for a year, to see how long immunity lasts, how well the vaccines work, and to figure out whether people who’ve had the virus can pass it to others. The program seeks to speed development of coronavirus vaccines and treatments in the United States. Gustave Perna.

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The Pharma Data

FEBRUARY 1, 2021

Protesters Close Down LA COVID-19 Vaccination Site. A few dozen anti-vaccination protesters closed down a coronavirus vaccination super site at Los Angeles’ Dodger Stadium for about 55 minutes on Saturday. © 2021 HealthDay. Posted: February 2021. “The LAPD responded and the site resumed operations.

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The Pharma Data

DECEMBER 4, 2021

In the first head-to-head comparison of the effectiveness of the Pfizer-BioNTech and Moderna COVID-19 vaccines, researchers examined the electronic health records of veterans who had received each vaccine. Both vaccines were highly effective in preventing COVID-19 outcomes such as documented infection, hospitalization, and death.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. There is hope that Moderna’s vaccine could be available by early 2021. .

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Eye on FDA

JANUARY 12, 2022

During nearly all of 2021, FDA has been under the direction of an acting commissioner. COVID – 144 announcements were COVID-related in 2021, compared to 274 such announcements during 2020; Approvals – there were 77 announcements related to approvals this year, 22 of which were COVID-related announcements.

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The Pharma Data

APRIL 20, 2022

Results of a new multicenter study published in the New England Journal of Medicine found that vaccination with a primary series of the Pfizer-BioNTech mRNA COVID-19 vaccine reduced the risk of COVID-19-associated hospitalizations in children ages 5-11 years by two-thirds during the Omicron period.

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The Pharma Data

JANUARY 12, 2021

WHO and Partners to Stockpile Ebola Vaccine. 12, 2021 — Ebola vaccines are being stockpiled by the World Health Organization and other groups to combat future outbreaks of the deadly disease. © 2021 HealthDay. Posted: January 2021. Professional. TUESDAY, Jan. Nearly 7,000 doses are currently available.

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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Eye on FDA

JULY 19, 2021

But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. Last year the agency issued over 400 releases on a range of topics (65 percent of releases were related to COVID-190. Last year the agency issued over 400 releases on a range of topics (65 percent of releases were related to COVID-190.

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The Pharma Data

DECEMBER 30, 2020

Food and Drug Administration (FDA), noted in December 2020 that he expected the pandemic could “effectively” be ended in 2021 with the launch of the Pfizer-BioNTech and Moderna vaccines. AstraZeneca and University of Oxford COVID-19 vaccine authorization. Johnson & Johnson’s COVID-19 vaccine. .

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The Pharma Data

JANUARY 10, 2021

When our backs were against the wall, the biotech/biopharma community came together to create not one, but two vaccines currently approved for emergency use in the U.S. I think most of what will happen in 2021 is an absolute direct result of the things the world has gone through in 2020. This has earned the industry a lot of respect.

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The Pharma Data

MAY 4, 2021

Posted 04 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. EMA. . . . . .

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The Pharma Data

JANUARY 14, 2021

There’s no evidence that coronavirus vaccines will be less effective against this Columbus variant, said study co-author Peter Mohler. “At this point, we have no data to believe that these mutations will have any impact on the effectiveness of vaccines now in use,” Mohler told CBS News. © 2021 HealthDay.

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The Pharma Data

JANUARY 27, 2021

Government to Increase Vaccine Deliveries to States. 27, 2021 — In response to COVID-19 vaccine shortages, the U.S. Vaccine shortages have forced some vaccination sites across the country to cancel tens of thousands of appointments. © 2021 HealthDay. Posted: January 2021. Professional.

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The Pharma Data

JANUARY 13, 2021

Brazil’s Butantan Institute has reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 The researchers previously said that the vaccine offered 78 percent efficacy against mild-to-severe infections, but they failed to include data from volunteers who contracted mild cases.

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