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News

Germany ‘won’t approve’ AstraZeneca vaccine for over-65s – Independent

Germany has recommended the AstraZeneca coronavirus vaccine should only be given to people under the age of 65, according to reports.

The country’s vaccine committee has reportedly said the jab, developed alongside the University of Oxford, should only be offered to people aged between 18 and 64.

It gave a lack of sufficient data on the effectiveness of the inoculation in older people as the reason for the decision in a draft recommendation.

https://www.independent.co.uk/news/world/europe/astrazeneca-covid-vaccine-germany-elderly-b1794128.html

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Opinion

Regulation and Uptake of the COVID-19 Vaccine – Kingsley Napley

The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.

https://www.kingsleynapley.co.uk/insights/blogs/public-law-blog/regulation-and-uptake-of-the-covid-19-vaccine

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Publications

Anaphylaxis Following m-RNA COVID-19 Vaccine Receipt – CDC

  • December 9 – UK authorities confirmed 2 cases of anaphylaxis after vaccination
  • December 18*, 2020 – CDC has identified 6 case reports of anaphylaxis following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for anaphylaxis
  • Persons with anaphylaxis following COVID-19 vaccination should not receive additional doses of COVID-19 vaccine

https://web.archive.org/web/20201219174137/https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/05-COVID-CLARK.pdf

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News

Hospital worker with no prior allergies in intensive care with severe reaction after Pfizer Covid vaccine – METRO

A hospital worker with no history of allergies was admitted to intensive care over a severe reaction she suffered 10 minutes after having Pfizer’s coronavirus vaccine. The unidentified female worker suffered an anaphylactic reaction shortly after receiving the injection at a hospital in Juneau, Alaska, on Tuesday.

Two healthcare workers in the UK suffered an anaphylactic reaction to the Pfizer injection after being given it last week, although the vaccine has been widely tested and analysed, with government experts in both the US and Great Britain deeming it safe.

https://web.archive.org/web/20201216200555/https://metro.co.uk/2020/12/16/hospital-worker-in-intensive-care-after-suffering-severe-allergic-reaction-to-covid-vaccine-13763695/

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News

Dozens of GP practices in England opt out of Covid vaccine rollout – The Guardian


More than 100,000 patients will not be able to get the Covid vaccine from their family doctor after their GP surgeries decided not to take part in its deployment, the Guardian can reveal.

https://web.archive.org/web/20201211122855/https://www.theguardian.com/society/2020/dec/11/gp-practices-england-opt-out-covid-vaccine-rollout

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News

White House Reportedly Told FDA Head: Approve Vaccine Today Or Resign – Forbes

White House chief of staff Mark Meadows told the head of the Food and Drug Administration on Friday to either sign off on Pfizer’s coronavirus vaccine by the end of the day or hand in his resignation, the Washington Post reported, another push by the White House to approve the vaccine as quickly as possible after a panel of scientists ruled it safe this week.

http://archive.today/2021.10.01-091702/https://www.forbes.com/sites/joewalsh/2020/12/11/white-house-reportedly-told-fda-head-approve-vaccine-today-or-resign/?sh=3d4ac9d21a0e

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News

Pfizer given protection from legal action by UK government – The Independent

The UK government has granted pharmaceutical giant Pfizer a legal indemnity protecting it from being sued, enabling its coronavirus vaccine to be rolled out across the country as early as next week.

The Department of Health and Social Care has confirmed the company has been given an indemnity protecting it from legal action as a result of any problems with the vaccine.

Ministers have also changed the law in recent weeks to give new protections to companies such as Pfizer, giving them immunity from being sued by patients in the event of any complications.

NHS staff providing the vaccine, as well as manufacturers of the drug, are also protected.

https://web.archive.org/web/20201202182311/https://www.independent.co.uk/news/health/coronavirus-pfizer-vaccine-legal-indemnity-safety-ministers-b1765124.html

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Publications

Public needs to prep for vaccine side effects – Science

Most people will escape “severe” side effects, defined as those that prevent daily activity. Fewer than 2% of recipients of the Pfizer and Moderna vaccines developed severe fevers of 39°C to 40°C. But if the companies win regulatory approvals, they’re aiming to supply vaccine to 35 million people worldwide by the end of December. If 2% experienced severe fever, that would be 700,000 people.

Other transient side effects would likely affect even more people. The independent board that conducted the interim analysis of Moderna’s huge trial found that severe side effects included fatigue in 9.7% of participants, muscle pain in 8.9%, joint pain in 5.2%, and headache in 4.5%. In the Pfizer/BioNTech vaccine trial, the numbers were lower: Severe side effects included fatigue (3.8%) and headache (2%).

But that’s a higher rate of severe reactions than people may be accustomed to. “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones,” says Arnold Monto, an epidemiologist at the University of Michigan School of Public Health.

https://web.archive.org/web/20201126203444/https://science.sciencemag.org/content/370/6520/1022

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News

The AstraZeneca Covid Vaccine Data Isn’t Up to Snuff – Wired

  • Vaccine produced by a partnership between a University of Oxford research institute, Vaccitech, and AstraZeneca, does not need to be stored at freezing temperatures.
  • Cheaper and easier to produce than the high-efficacy vaccines produced by BioNTech-Pfizer and Moderna.
  • The price of AstraZeneca’s shares dropped on the news, and an analysis from an investment bank concluded, “We believe that this product will never be licensed in the US.”
  • A closer look at the the Oxford-AstraZeneca trials reveals some very shaky science.
    • Cherry-picked the data
    • Dosing issues
    • Opaque planning and data analysis procedures
    • Age group selection

https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

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News

The Case for a Coronavirus-Vaccine Bond – The New Yorker

Drugs are a risky business and, for equity investors hoping to eventually share in the profits, each stage of development presents an escalated risk. Lo reasoned that substantially lowering the risks, even if it meant correspondingly lowering the rewards, could attract investment instead from ordinary bond markets—that is, from managers of pension funds, university endowments, and sovereign-wealth funds, who control a great deal of money and generally invest in low-risk, low-return assets. 

Given how uncertain vaccine markets are, the paper notes, governments (“public-sector interventions,” and so forth), would need to guarantee a vaccine bond by committing in advance to purchase and stockpile vaccines. The paper’s most creative suggestion is for a subscription model, a kind of vaccine Netflix, where governments would pay an annual fee to a new international-development fund, one that could perhaps be managed by the G7. The fund could float a bond to both advance vaccine biotechs and to make market commitments to Big Pharma. The virus, the markets, and the science are global.

…it would be much better for the government to say that the money is not from taxpayers. “We’re borrowing it from the rest of the world. And if and when you succeed, or any of the other hundred and fifty projects—that could have been funded, but aren’t being funded right now—succeeds, all the bond holders will get paid. That would be great. Everybody earns a return.”

http://archive.today/2020.08.15-143205/https://www.newyorker.com/news/daily-comment/the-case-for-a-coronavirus-vaccine-bond

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Publications

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals – ClinicalTrials.gov

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

Actual Study Start Date  :April 29, 2020
Estimated Primary Completion Date  :October 29, 2021
Estimated Study Completion Date  :April 6, 2023

https://clinicaltrials.gov/ct2/show/NCT04368728