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Covid Vaccine & Research Info

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Coronaviruses: are medium sized, enveloped, positive-stranded ribonucleic acid (RNA) viruses, with a characteristic crown-like appearance in electron micrographs due to circumferential studding of the viral envelope with projections comprising the spike (S) protein.

Other Coronoviruses
Zoonotic: In addition, other coronavirus strains are widespread in animals, where they typically cause enteric disease.
Human: There are 4 different strains (229E, OC43, NL63, and HKU1), which are ubiquitous in humans and generally result in mild upper respiratory illnesses and other common cold symptoms including malaise, headache, nasal discharge, sore throat, fever, and cough [Su 2016].
Previous Species Jumps: These zoonotic coronaviruses have been known to evolve into strains that can infect humans with serious consequences including;

  • Severe Acute Respiratory Syndrome (SARS) 2002-3
  • Middle Eastern Respiratory Syndrome (MERS) 2012
  • novel SARS-CoV-2 (C-19) since 2019.
TimelineIt took 67 days from the first reported case to reach the first 100,000 cases, 11 days for the second 100,000 cases and just 4 days for the third 100,000 cases" Dr Tedros Ghebreyesus, WHO Director general.
  • December 8th = First cases in Wuhan
  • January 1st = Lockdown of Wuhan market
  • January 7th = Identification SARS CoV-2
  • January 10th = Complete sequence SARS CoV-2 genome
  • January 13th = First cases outside China
  • January 20th = Human transmission shown
  • January 23rd = Lockdown of Wuhan
  • January 30th = WHO declares PHEIC
  • March 11th = WHO declares Pandemic
Transmission
  • Predominant person-to-person transmission via respiratory droplets (>5 µm diameter, max travel 6 ft/2 m) from infected person coughing/sneezing: • Contact with mucous membranes • Direct contact with infected surface followed by contact with eyes, nose or mouth
  • Transmission through the airborne route (through particles smaller than droplets that remain in the air over time and distance) remains controversial
  • SARS-CoV-2 can be detected in non-respiratory specimens, such as stool, blood, ocular secretions, and semen - The role in transmission is uncertain
Viral Shedding & Infectivity Window
  • SARS-CoV-2 can be transmitted prior to symptoms development (incubation phase) and throughout the course of illness (symptomatic disease)
  • Results of one study from China: • infectiousness started 2.3 days prior to symptom onset • peaked 0.7 days before symptom onset • and declined within seven days (mean 5.8 days)
  • Risk of infection varies by the type and duration of exposure, use of preventive measures, and individual factors
  • Transmission of SARS-CoV-2 from asymptomatic individuals has been well documented
SARS-CoV-2 Immunity
  • Seroconversion i.e. detection of IgG and IgM antibodies against the receptor-binding domain of SARS-CoV 2 spike protein occurred in 50% of patients by day 7, and in all patients by day 14
  • Unknown if there is cross-reactivity or cross-stimulation against the four endemic human coronaviruses?
  • Seroconversion does not necessarily mean immunity to reinfection
  • It is uncertain that all infected patients build a protective antibodies and how long their protective effect will last
Symptoms
  • Nonspecific symptoms resembling other viral respiratory infections
  • Uncomplicated disease resolve within 2 weeks without any sequelae
  • Most common symptoms in hospitalized patients, study from Wuhan [1-3]:
  • • Fever (83–99%)
  • • Cough (59–82%)
  • • Fatigue (44–70%)
  • • Anorexia (40–84%)
  • • Shortness of breath (31–40%)
  • • Sputum production (28–33%)
  • • Myalgia (11–35%)
  • • Smell and taste disorders relatively common

UK/ Kent - B 117

Virulence

Recent studies suggest the UK variant of coronavirus (B117) is linked to a higher chance of hospitalisation and death than the original strain: A recent study by the University of Exeter and Bristol assessed samples from 54,906 people who had tested positive for the UK strain, against people who had tested positive for other strains. The study showed that the UK strain led to 227 deaths among 54,906 patients, compared to 141 deaths in the group of the same size with other coronavirus strains. That means the UK strain could be 64 per cent more deadly.


Pfizer BioNTech

Early results from lab studies show that the Pfizer/BioNTech vaccine offers a good level of protection against mutations found in the UK variant (B.1.1.7). While further research is ongoing, it’s likely that the vaccine will still help protect against this strain


AstraZeneca

A study on the Oxford/AstraZeneca vaccine shows that it offers good protection against the UK variant of coronavirus (B.1.1.7). This is good news given this is the most common strain in the UK now.The study showed that this vaccine offers 75% effectiveness against the UK strain, compared to 84% against the initial strain. This is well above the 50% minimum level of protection that is recommended by the World Health Organization.

South Africa - B 1351

Virulence

The South African strain is not believed to be more deadly than the initial strain, but it is known to spread more quickly than the initial strain.


Pfizer BioNTech

Early results from a New York University study show that the Pfizer/BioNTech vaccine also offers protection against the South African variant, though this study only included a very small number of people. There is some evidence from lab studies that antibodies made in response to the Pfizer vaccine are less effective against the South African variant – but this does not necessarily mean the vaccine will not still give protection. More research is needed into this area.


AstraZeneca

A small study of 2,000 people in South Africa has shown that the Oxford/AstraZeneca vaccine offers minimal protection against mild cases of the South African variant. The study, which was based people of an average age of 31, shows that protection may be as low as 10%. The research wasn’t able to determine whether it protects against serious illness or hospitalisation, because this group of people were at low risk of serious illness. Other research suggests that the vaccine is still likely to reduce severe cases and deaths from the South African strain. More research is needed in this area.
Oxford University is working on adapting the vaccine to ensure that it protects against this variant, as well as other strains. They have said a ‘booster’ jab could be available by autumn 2021.

Brazil/ Japan - P 1

Virulence

The Brazilian strain is not believed to be more deadly, but it does spread more easily than the original Covid-19 strain.


Pfizer BioNTech

Early results from lab studies have showed that antibodies made in response to the Pfizer/BioNTech vaccine are still active against mutations found in the Brazil variant. More research is needed to be sure of how effective the vaccine is against the Brazilian variant.


AstraZeneca

We don’t yet have good evidence on how effective the Oxford/AstraZeneca vaccine is against the Brazilian variant. When more information is available, we will publish it here.

https://www.mayoclinic.org/covid-variant/expert-answers/faq-20505779
https://www.bhf.org.uk/informationsupport/heart-matters-magazine/news/coronavirus-and-your-health/covid-variant
https://www.biospace.com/article/comparing-covid-19-vaccines-pfizer-biontech-moderna-astrazeneca-oxford-j-and-j-russia-s-sputnik-v/

Brazil - P 2

New York - B 1526

Virulence

We don’t yet know whether the B1.525 variant is more deadly, or spreads more easily, than other strains of coronavirus. The B1.525 variant and has similarities to the Kent variant, including the E484K mutation. This mutation can make the virus more transmissible, and more resistant to antibodies, so more research needs to be done.


Pfizer BioNTech

We don’t yet know how effective the Pfizer or Oxford vaccines will be at protecting against the B1.525 variant. As the B1.525 strain has some of the same mutations as the Kent strain, updates to the vaccine may provide increased protection against other variants, like B1.525.


AstraZeneca

We don’t yet have good evidence on how effective the Oxford/AstraZeneca vaccine is against the New York variant. When more information is available, we will publish it here.

California - B 1427 & B 1429

India - B 1617

mRNA Genetic


Pfizer BioNTech & Moderna

Viral Vector


Astra Zeneca, Janssen & (Sputnik)

Protein Unit/ Subunit


Novavax

Traditional Inactivated


Valneva,Bharat Biotech & Sinovac

Traditional Attenuated


Codagenix

Oxford/AstraZeneca (ChAdOx1 nCoV-19 [AZD1222])


Formulation, Dosing & Price

• Non-enveloped dsDNA virus, 90nm
• Non-replicating due to E1 (and E3) gene deletion
• Using a simian adenovirus avoids issues with pre-existing immunity to human adenoviruses
• Antigen-encoding transgene under strong constitutive mammalian promoter :: Antigen is expressed at high level after vaccination, inducing strong B and T cell responses
Storage @ 2'c ==> 6m > Store at 2–8ºC. Shelf life is 6 months.
After opening, store at 2–25˚C and use within 6 hours.
Two doses, 28d
$2-5

Effectiveness

vs Transmission: 67% (vs non-B117 [1]) :: 29% (vs B117 variant [2])
Scottish and English studies have shown that family members of index cases are 30-40% less likely to contract infection.
vs Mild: tbc
vs Moderate: 86%
vs Severe: 100% [3]
vs Death: 100% [3]
Duration:
[1] Lancet 02/02/2021 :: [2] Lancet 30/03/2021 :: [3] study in 32,449 participants in the US, Peru and Chile on 25 March 2021

New Variants

Mixed effectiveness
UK variant (B.1.1.7): Even though x9 reduction in [antibody], B117 Symptomatic case rate reduced by 70%, non-B117 reduced by 80% (Lancet 30/3/2021)
South African variant (B.1.351): There is a x12 reduction in [antibody] against this variant and case rate of this variant seems to be reduced by about 10% following Az.
Brazilian variant (P1): A small laboratory study using vaccine sera suggests antibody titres were reduced by 2.9-fold against this variant.

Safety

EMA, MHRA & JCVI have all reviewed "thrombotic events in setting of low platelet counts"
79 Cases in UK (out of >20 mill doses) :: xx cases in Germany / Sweden :: Postulated Mechanism - univ of olso
- 18-29yo should not have Az (unless very high risk of harm from a covid inf)
- People with high risk of thrombosis should avoid/ carefully consider risks of Az
- Recipients should be medically assessed for any post-vaccination "new onset of severe or persistent headache, blurred vision, confusion or seizures, shortness of breath, chest pain, leg swelling or persistent abdominal pain, and unusual skin bruising or pinpoint round spots beyond the injection site"

Pfizer/BioNTech (BNT162b2)


Formulation, Dosing & Price

- Nucleoside-modified mRNA vaccine that encodes trimerised SARS- CoV-2 spike
- Lipid nanoparticle delivery
- mRNA degraded within days
Storage @ -80'c ==> 6m
Store between -80°C and -60°C. Shelf life is 6 months.
After thawing, undiluted vaccine can be stored for up to 5 days at 2–8°C,
and up to 2 hours at temperatures up to 25°C.
Once diluted, store at between 2–25˚C and use within 6 hours.
Two doses, 21d
$20

Effectiveness

vs Transmission: 72% vs sympto & asympto at 21d and 86% redcn in transmission after booster
- Isreali data shows lower viral loads in the pts who do contract covid after vaccine
- Scottish healthcare worker index case study shows 30% reduction in transmission to family etc.
vs Mild:symptomatic 94.6% published :: real-world data suggests 85% redn in sympto spread
vs Moderate: 95% reducn in Hospitalisation
vs Severe: tbc%
vs Death: 72% reduction%
Duration: at least 6m (CDC published on 01/04/2021, showed 91%, 95% & 100% effectiveness after 6m)

New Variants

Yes, but effectiveness may be reduced against some variants and more data are needed.
UK variant (B.1.1.7): A small laboratory study using vaccine sera suggests roughly equivalent neutralisation of this variant. And data from the UK vaccination programme, published as pre-prints on 1 March 2021 and 23 April 2021, and the PHE SIREN study, suggest vaccine efficacy is still high against B.1.1.7.
South African variant (B.1.351): A small laboratory study using vaccine sera suggests a 10.3-fold reduction in antibodies that neutralise this variant. However, analysis of 800 participants in Pfizer/BioNTech’s phase III trial, announced by the companies on 1 April 2021, shows nine cases of COVID-19 in the placebo group, six of which were due to B.1.351, and none in the vaccine group, suggesting vaccine efficacy of 100% (95% CI 53.5–100.0).
Brazilian variant (P1): A small laboratory study using vaccine sera suggests roughly equivalent neutralisation of this variant, although two other laboratory studies, published as preprints, suggest antibody titres were reduced by 2.6-fold and 14-fold. The impact is yet to be confirmed in clinical trials.

Safety

The safety profile reflects that seen in clinical trials (injection-site reactions and generalised ‘flu-like’ symptoms).

Moderna (mRNA-1273)



Formulation, Dosing & Price

- Nucleoside-modified mRNA vaccine that encodes trimerised SARS-CoV-2 spike
- Lipid nanoparticle delivery
- mRNA degraded within days
Storage @ -25'c ==> 7m Store between -25º and -15ºC. Shelf life is 7 months.
Once thawed, unopened vials can be stored at 2–8 °C for up to 30 days
or at 8– 25°C for 12 hours.
After opening, store at 2–25˚C and use within 6 hours.
Two doses, 28d
$25-37

Effectiveness

vs Transmission: unconfirmed, early submission to FDA ... 60% after 1 dose & 90% after 2doses %
vs Mild: 94.1%
vs Moderate: tbc%
vs Severe: 100%
vs Death: tbc%
vs Duration: phase III COVE study announced by Moderna on 13 April 2021 ==> 95% at 6m

New Variants

Effectiveness may be reduced against some variants and more data are needed.
UK variant (B.1.1.7): A small laboratory study suggest no significant difference, but this is yet to be demonstrated in clinical trials.
South African variant (B.1.351): A small laboratory study suggest a 6.5-fold reduction in antibodies that neutralise this variant, but this is yet to be demonstrated in clinical trials.
Brazilian variant (P1): A small laboratory study suggests antibody titres are reduced by 2.6-fold. The impact is yet to be confirmed in clinical trials.

Safety

The safety profile reflects that seen in clinical trials (injection-site reactions and generalised ‘flu-like’ symptoms).

Novavax (NVX-CoV2373)



Formulation, Dosing & Price

• Trimeric Spike protein based vaccine. Each attached to a nanoparticle.
• Adjuvanted with sapnonin-based Matrix M1 adjuvant.
• Reported efficacy 60-96.4% depending on source and variant.
Storage @ 2'c ==> ??shelf life?
Two doses, 21d
$16

Effectiveness

vs Transmission: tbc - animal studies suggest 100% (!)
Mild: announced not published data (15/03/2021) 89.7% protection against symptomatic infections vs Moderate: tbc%
vs Severe: 100% (same novavax announcement showed 5 cases in placebo and 0 in vaccine group)
vs Death: tbc%

New Variants

Effectiveness may be reduced against some variants and more data are needed.
UK variant (B.1.1.7): Data from Novovax suggests 86.3% (95% CI 71.3–93.5) against symptomatic infection.
South African variant (B.1.351): Data from Novovax suggests 48.6% (95% CI 28.4–63.1) against symptomatic infection, 55.4% (95% CI 35.9–68.9) in HIV-negative participants.
Brazilian variant (P1): No evidence yet.

Safety

Analyses of the UK and South Africa trials showed that the vaccine is well-tolerated, with low levels of severe, serious and medically attended adverse events at day 35, balanced between vaccine and placebo group.

Janssen (Ad26.COV2.S)



Formulation, Dosing & Price

• Trimeric Spike protein based vaccine. Each attached to a nanoparticle.
• Adjuvanted with sapnonin-based Matrix M1 adjuvant.
• Reported efficacy 60-96.4% depending on source and variant.
Storage @ 2'c ==> shelflife?
Two doses, 21d
$16

Storage (-20'c=24m or +2'c=6m)

Store at -20ºC for 2 years or 2–8ºC for 3 months.

Effectiveness

vs Transmission: 66.1%
vs Moderate: 72.0%
vs Severe: 85.4%
vs Death: 100%
qv. NEJM 21/04/2021

New Variants

Effective, although more data are needed. UK variant (B.1.1.7): Phase III study did not include UK participants. South African variant (B.1.351): Phase III trial data suggest vaccine efficacy is 64.0% (95% CI 41.2–78.7) against moderate to severe/critical disease, and 81.7% (95% CI 46.2, 95.4) against severe/critical disease. Brazilian variant (P1): Phase III trial data suggest vaccine efficacy is 68.1% (95% CI 48.8, 80.7) against moderate to severe/critical disease and 87.6% (95% CI 7.8, 99.7) against severe/critical disease, although P1 was detected in 30.6% of sequences and P2 was detected in 69.4% of sequences.

Transmission ~65% redn

Probably effective, but more data needed. Phase III trial data show the vaccine reduced the risk of infection in a subgroup of 2,650 participants by 65.5% (95% CI 39.91–81.08), suggesting an impact on transmission, but this finding needs to be further investigated with additional data.

Safety

The safety profile in clinical trials includes injection-site reactions and generalised ‘flu-like’ symptoms. Administration of the Janssen vaccine in the US was temporarily paused on 13 April 2021 while the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) review data on six reported cases of blood clots with low platelets after receiving the vaccine among more than 6.8 million doses administered. Use of the vaccine resumed on the recommendation of the FDA and CDC on 24 April 2021, which said that a warning should now be included on the vaccine label about an elevated, but rare, risk of blood clots with low platelets. The European Medicines Agency (EMA) has also reviewed four cases of blood clots and low platelets among vaccine recipients in clinical trials and the US vaccination programme. On 20 April 2021, the EMA concluded that the overall benefit/risk ratio for the vaccine remains positive but said that a warning about unusual blood clots with low platelets should be added to the product information and that these events should be listed as very rare side effects of the vaccine.

Valneva (VLA2001)



Formulation, Dosing & Price

-
-
-
xx doses, xx d: $xx

Storage (-20'c=24m or +2'c=6m)

Store at -20ºC for 2 years or
2–8ºC for 3 months.

Effectiveness

vs Transmission: tbc%
vs Moderate: tbc%
vs Severe: tbc%
vs Death: tbc%

New Variants

??? Effective, although more data are needed. UK variant (B.1.1.7): South African variant (B.1.351): Brazilian variant (P1):

Safety


References:
https://www.immunology.org/coronavirus/connect-coronavirus-public-engagement-resources/types-vaccines-for-covid-19
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
https://pharmaceutical-journal.com/article/feature/everything-you-need-to-know-about-covid-19-vaccines
https://www.biospace.com/article/comparing-covid-19-vaccines-pfizer-biontech-moderna-astrazeneca-oxford-j-and-j-russia-s-sputnik-v/