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Wednesday, December 30, 2020

Covid-19 Vaccination — The Latest Developments


Source: @EricTopol

Latest Developments

01/24/2022

T cell responses to early variants were preserved across vaccine platforms. By contrast, significant overall decreases were observed for memory B cells and neutralizing antibodies. Functional preservation of the majority of T cell responses may play an important role as second-level defenses against diverse variants.[56] 


01/26/2021

This new work, published in the journal Science, utilizes a technology called a mosaic nanoparticle vaccine platform.[55] 
For the vaccine, Bjorkman and her colleagues used RBD proteins from up to eight viruses—including the original SARS-CoV-2 and other SARS-like coronaviruses isolated from bats—that were fused onto a nanoparticle with 60 faces. By injecting this vaccine into mice, Björkman and her colleagues found the animals produced diverse antibodies, which in follow-up experiments blocked infections caused by several SARS-like viruses, including coronavirus strains not used to create the vaccines.
The findings raise the exciting possibility that this new vaccine technology could provide protection against many coronavirus strains with a single shot.

12/26/2021

We’ve been working for years on a pan-vaccine for other viruses, like HIV-1, influenza, malaria, Epstein-Barr (NCT03186781; NCT03814720; NCT04579250; NCT04645147; NCT04296279), but no vaccine has successfully made it through clinical trials thus far. The difference for SARS-CoV-2 is that it mutates far less than HIV or influenza, making it more ideally suited for such an approach. If any universal vaccine makes it through the rigorous clinical trial process, it will be a big leap in medicine and science.

12/16/2021

Dr. Justin Groode
Science is plugging along and new vaccines will emerge that work far better because will not rely on the spike protein. My top pick is MigVax, an oral vaccine in human trials that provides IgG & IgA to spike and also 2 non-spike proteins that do not mutate, plus cell-mediated.

10/05/2021

Researchers from Royal Holloway, University of London, have now identified the first genetic link which could make people more predisposed to Cerebral Venous Thrombosis (CVT) which the condition became more prominent in the last year because of its possible link with the AstraZeneca vaccine.

The area of the human genome that strongly correlates with CVT is located in the same region as the blood group gene, the researchers said.  Here is the probability of CVT risk among different blood groups: 
  • AB blood group
    • had a 5.6 times increased risk of CVT
  • A or B blood type
    • had almost a 3 times increased risk of CVT 
compared to blood group O.[53]


08/24/2021

Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a life-threatening and mysterious condition that affects a very small number of people who have received the Oxford–AstraZeneca or Johnson & Johnson (J&J) COVID-19 vaccines. It is now estimated that VITT occurred in about 1 in 50,000 people aged under 50 who received the Oxford–AstraZeneca vaccine.[51]

Since he saw the first cases in March, the United Kingdom has changed its vaccination policy, and now recommends the Oxford–AstraZeneca vaccine only for people over 40. VITT is more frequent in younger vaccine recipients, possibly because of their more-robust immune responses.

People with a history of heparin induced thrombocytopenia (HIT) or cerebral sinus vein thrombosis (CSVT) with low platelets are at increased risk of VITT; they should receive an mRNA vaccine (Pfizer or Moderna) rather than an adenoviral vector vaccine.[52]


07/16/2021

Messenger RNA vaccines against COVID-19 were not detected in human milk, according to a small study by UC San Francisco, providing early evidence that the vaccine mRNA is not transferred to the infant.[50]

07/03/2021

A Next Generation Bivalent Human Ad5 COVID-19 Vaccine Delivering Both Spike and Nucleocapsid Antigens Elicits Th1 Dominant CD4+, CD8+ T-cell and Neutralizing Antibody Responses.[49]

07/01/2021

Researchers at La Jolla Institute for Immunology (LJI) have found that T cells from people who have recovered from COVID-19 or received the Moderna or Pfizer-BioNTech vaccines are still able to recognize several concerning SARS-CoV-2 variants.[48]


05/05/2021

A study suggests that vaccination-generated antibody and/or exogenous antibody against S protein not only protects the host from SARS-CoV-2 infectivity but also inhibits S protein-imposed endothelial injury.[46]

The Pfizer-BioNTech vaccine is incredibly effective against severe disease caused by two variants, study says.[47]


04/21/2021

The Digital Green Certificate proposed by European Commission will have three certificates included within it including:
  • Vaccination certificates, stating brand of the vaccine used, data and place of inoculation and number of doses administered.
  • Negative test certificates (either a NAAT/RT-PCR test or a rapid antigen test). Self-tests will be excluded for the time being.
  • Medical certificates for people who have recovered from COVID-19 in the last 180 days.

04/16/2021

The FDA, CDC Pause On Johnson & Johnson Covid-19 Vaccines—the pause is to give officials and scientists time to further investigate why six people in the U.S. developed cerebral venous sinus thrombosis (CVST), a rare but severe type of blood clot, after receiving the vaccine, and how to deal with this potential risk.[45]



04/02/2021

Side effect worry grows for AstraZeneca vaccine.[44]
  • The highly unusual combination of symptoms—widespread blood clots and a low platelet count, sometimes associated with bleeding—has so far been reported from at least seven countries.
  • So far, most of the clotting cases have been observed in women under age 65.

02/26/2021

Simple explainer for the potential asymptomatic carrier state after vaccines and why we still need masks for a stretch


02/24/2021

Pfizer/BioNtech And Moderna MRNA Covid-19 Vaccines Closely Mimic The Immune Response Of Natural SARS-CoV-2 Infections.[41]


02/08/2021

The optimistic mood around COVID-19 vaccine rollouts has been clouded by new variants of the virus, which could trample the efficacy of vaccines or escape them entirely.[40]

 
02/03/2021

Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination.[39]


01/29/2021

In an interim analysis of a phase 3 clinical trial conducted in the UK, the Novax vaccine has shown 89% efficacy, with 27% of participants in the trial – almost 4,000 people – older than 65. That trial suggested 95.6% efficacy against the original coronavirus and 85.6% efficacy against the more recent UK variant.[37]

The overall efficacy of J&J vaccine is 66%, but 72% in the US. That disguises some very important and exciting results. First, the vaccine had 85% efficacy against severe disease anywhere in the world – which includes South Africa where almost all participants had the variant form of the virus. That is hugely reassuring for the vaccine effort. Second, nobody in the trials who was given the vaccine was admitted to hospital or died – so 100% efficacy against the worst outcomes.[37]


01/20/2021

The new COVID-19 variant identified in South Africa can evade the antibodies that attack it in treatments using blood plasma from previously recovered patients, and may reduce the efficacy of the current line of vaccines, scientists said on Wednesday.

More than ten companies are coming together to make a digital vaccine card for Covid-19.[36]


01/17/2021

Germany says new COVID variants require new measures.[33]


01/15/2021

Norway Warns of Vaccination Risks for Sick Patients Over 80.[31]


01/14/2021

Europe Considers Vaccine Certificate to Boost Travel and Economy.[32]
Over a video conference on Jan. 21, European Union leaders will discuss the introduction of a “vaccination certificate” that would allow holders to travel freely

01/12/2021

A research showed that NSAIDs may alter the immune response to SARS-CoV-2 vaccination.[30]


01/10/2021

Japan’s Ministry of Health said the four passengers who arrived at Japan’s Haneda airport from Brazil on Jan. 2 were later diagnosed with a variant of the virus. One male in his 40s, who was asymptomatic upon arrival, was hospitalized as his respiratory system worsened.[28]

Confirmed Reinfection with SARS-CoV-2 Variant VOC-202012/01.[29]


01/04/2021

A new variant of the novel coronavirus identified in South Africa is "even more of a problem" than the highly contagious strain spreading rapidly in the United Kingdom, according to U.K. Health Secretary Matt Hancock.[27]

12/30/2020

Britain grants approval to coronavirus vaccine by Oxford and AstraZeneca[26]

12/29/2020

Spain Plans A "Registry" For Those Who Refuse COVID Vaccine[25]

12/28/2020

Vaccine overdose puts German care workers in hospital:[23]
Vorpommern-Ruegen district authorities said the workers in Stralsund city received five times the recommended dose of the BioNTech-Pfizer vaccine on Sunday. Four went to hospital for observation after developing flu-like symptoms.
Travel Insurers Likely To Make Vaccination A Requirement, New Report Finds[24]

12/24/2020

New Coronavirus Strain: Will Vaccines Still Work On Variant Found In The U.K.?[21]
The new variant has 17 mutations within it, of which 8 are affect the gene that codes for the spike protein. 
But, “relative to the size of the protein, the new variant still harbors few changes,” Professor Martin Michaelis of the University of Kent’s School of Biosciences said.

Immune responses, he added, tend to target multiple sites of a protein. So these changes aren’t expected to have a substantial impact on how well the vaccines work. But he cautioned: “only time and more research will provide a definitive answer to this question.” 
12/26/2020

Scientists Scramble To Identify Culprit Behind Covid Vaccine Allergic Reactions:[22]
For now, the CDC says people who have a history of severe allergic reactions to any component of the Pfizer-BioNTech or Moderna vaccines should not receive the vaccine, and those who have a severe allergic reaction after the first dose should not receive the second. The agency also says people who get the shots should be observed for 15 minutes after vaccination to monitor for possible adverse reactions. People with a history of anaphylaxis should be observed for 30 minutes, it says.
12/19/2020

FDA investigating five allergic reactions after Pfizer shot in U.S.[18]

12/18/2020

South Africa identifies new coronavirus strain causing surge in cases.[16]

FDA grants authorization to Moderna’s Covid-19 vaccine, the second in the U.S.[17]

12/17/2020

FDA Briefing Document — Moderna COVID-19 Vaccine (link)

Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 years of age and older?

Yes: 20 / No: 0 / Abstain: 1


12/15/2020
Vaccination may protect the individual but not their contacts,” says Emily Hyle, an infectious disease physician at Massachusetts General Hospital in Boston. “We need more information before using vaccination status to change guidance about masking and social distancing.”[12]
A health worker in Alaska had a serious allergic reaction after getting Pfizer Inc’s coronavirus vaccine.[13]
12/13/2020

The headline news says SARS-CoV-2 Reinfection Is Rare but Possible.  So, preventive measures are important, whether you’ve had COVID-19 or not.
“We expect immunity will wane in people who have been infected, but we don’t necessarily know how long that would take. We’re not seeing tremendous numbers of reinfections, which suggests that the immune response may last a while. But it’s very important to stress to patients that reinfections can happen – and that the symptoms of reinfection may be different than the first bout of illness. It is quite possible that a reinfected person may be less symptomatic or asymptomatic and still shed the virus, infecting their friends and loved ones,” said Dr. Esper.

12/12/2020

Peru suspended trials for China’s Sinopharm COVID-19 vaccine due to a “serious adverse event” that occurred with one of the volunteers for the study, the Peruvian government said in a statement on Saturday. One volunteer was said to had experienced decreased strength in his legs among other symptoms.[10]

12/11/2020

The Sanofi/GSK protein sub-unit vaccine is said to not work well enough in older people.

Australia halts home-made COVID vaccine production on HIV false positives.[19]

12/10/2020

A Food and Drug Administration panel voted 17 to 4, with one abstention, that the benefits of a vaccine developed by Germany-based BioNTech and U.S.-based Pfizer outweigh any risks.[8]


12/09/2020

People with a significant history of allergies should not currently receive the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, the U.K.’s National Health Service said, after two people experienced reactions from the shots.[5]

What exactly happened?

Two UK health care workers with a history of significant allergic reactions reported anaphylactoid reactions and are recovering well.

Anaphylactoid reactions are allergic reactions that share some of the characteristics of anaphylaxis but are less severe, said UK Drug Safety Research Unit Director Saad Shakir.  

Who Should Not Get the Vaccine? 

British regulators initially responded by saying anyone with a history of a significant allergic reaction to a vaccine, medicine or food should not take the shot. An adviser to the group later said it was “tweaking” advice in part to say a food allergy was not a risk.

Pfizer had excluded people with a history of significant adverse reaction to vaccines or its vaccine’s ingredients from late stage trials.

It was crucial, Alexander Gintsburg, the Sputnik vaccine’s developer said, to refrain from alcohol three days before and after the two injections required. He said such advice was the same for anyone getting vaccinated around the world and not specific to Russia or Sputnik.[6]

References

  1. What the FDA's review reveals about Pfizer's COVID-19 vaccine
  2. FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine
  3. COVID-10 Vaccine F&Q
  4. FDA Says 2 Participants In Pfizer COVID Vaccine Trial Have Died
    • To be sure, it's unclear whether the participants who died succumbed to vaccine-related complications, or whether they even received a vaccine at all (they could have received a placebo).
  5. U.K. Says Those With Severe Allergy Should Avoid Pfizer Shot
  6. Don't mix Sputnik vaccine with alcohol, says Russian official. Some recoil
  7. Explainer: What the UK cases of allergic reaction mean for Pfizer's COVID-19 vaccine
  8. Pfizer Shot Gets FDA Advisers’ Nod as Agency Decision Nears
  9. Vaccine bootcamp (nice animation)
  10. Peru suspends Sinopharm COVID-19 vaccine trial after 'adverse event'
  11. SARS-CoV-2 Reinfection Is Rare but Possible
  12. The Coronavirus Vaccine Could Be the Ultimate Gateway Drug
  13. Health worker in Alaska had serious allergic reaction after Pfizer's vaccine - NYT
  14. Yes, people who’ve had Covid-19 can still benefit from the vaccine
  15. Vaccination is the only acceptable path to herd immunity
  16. South Africa identifies new coronavirus strain causing surge in cases
  17. FDA grants authorization to Moderna’s Covid-19 vaccine, the second in the U.S.
  18. FDA investigating five allergic reactions after Pfizer shot in U.S
  19. Australia halts home-made COVID vaccine production on HIV false positives
  20. UKvariant with 9 mutations in the Spike Protein
  21. New Coronavirus Strain: Will Vaccines Still Work On Variant Found In The U.K.?
  22. Scientists Scramble To Identify Culprit Behind Covid Vaccine Allergic Reactions
  23. Vaccine overdose puts German care workers in hospital
  24. Travel Insurers Likely To Make Vaccination A Requirement, New Report Finds
  25. Spain Plans A "Registry" For Those Who Refuse COVID Vaccine
  26. Britain grants approval to coronavirus vaccine by Oxford and AstraZeneca
  27. South Africa variant 'even more of a problem' than UK strain, health secretary says
  28. Japan Says It Found New Coronavirus Variant Similar to U.K. Strain
  29. Confirmed Reinfection with SARS-CoV-2 Variant VOC-202012/01
  30. Non-steroidal anti-inflammatory drugs dampen the cytokine and antibody response to SARS-CoV-2 infection
  31. Norway Warns of Vaccination Risks for Sick Patients Over 80
  32. Europe Considers Vaccine Certificate to Boost Travel and Economy
  33. What you need to know about the coronavirus right now
  34. New COVID-19 variant defeats plasma treatment, may reduce vaccine efficacy
  35. Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States (CDC)
  36. The Big Tech Coalition Designing Digital Vaccine IDs For Covid-19
  37. Will Novavax and Johnson & Johnson Covid vaccines work against variants?
  38. Myths of Vaccine Manufacturing
  39. Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination
  40. Vaccines Versus the Mutants
  41. Pfizer/BioNtech And Moderna MRNA Covid-19 Vaccines Closely Mimic The Immune Response Of Natural SARS-CoV-2 Infections
  42. Pfizer/BioNtech And Moderna MRNA Covid-19 Vaccines Closely Mimic The Immune Response Of Natural SARS-CoV-2 Infections
  43. CD24-Exosomes (Clinical Trial)
  44. Side effect worry grows for AstraZeneca vaccine
  45. The reasons behind the FDA and the CDC pause on the Johnson & Johnson Covid-19 vaccines 
  46. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2
  47. Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
  48. Moderna and Pfizer-BioNTech vaccines prime T cells to fight SARS-CoV-2 variants
  49. A Next Generation Bivalent Human Ad5 COVID-19 Vaccine Delivering Both Spike and Nucleocapsid Antigens Elicits Th1 Dominant CD4+, CD8+ T-cell and Neutralizing Antibody Responses
  50. No Sign of COVID-19 Vaccine in Breast Milk
  51. COVID vaccines and blood clots: what researchers know so far
  52. Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) Following Adenovirus Vector COVID-19 Vaccination
  53. Clot risk linked to AstraZeneca vaccine could depend on which blood group you are
  54. Pan-coronavirus "super" vaccine
  55. Mosaic RBD nanoparticles elicit neutralizing antibodies against SARS-CoV-2 and zoonotic coronaviruses . Cohen AA, Gnanapragasam PNP, Lee YE, Hoffman PR, Ou S, Kakutani LM, Keeffe JR, Barnes CO, Nussenzweig MC, Bjorkman PJ. Science. 2021 Jan 12.
  56. SARS-CoV-2 vaccination induces immunological T cell memory able to cross-recognize variants from Alpha to Omicron
  57. Role of drug delivery technologies in the success of COVID-19 vaccines: a perspective

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