New covid 19 vaccines and trials

 SARS-CoV-2 is positive-sense, single-stranded RNA connected to a
nucleoprotein surrounded by a matrix protein based capsid
 A classic CoV has no less than six open reading frames (ORFs) in its
genome. All the structural and accessory proteins of CoVs are
translated from it’s single guide RNAs (sgRNAs) .
 Two big overlapping ORFs, ORF 1a and ORF 1b, encodes for four
conventional structural proteins in the sequential arrangement of
spike (S), envelope (E), membrane (M), and nucleocapsid (N) .
 Source:Das SK. The pathophysiology, diagnosis and treatment of corona virus disease 2019 (COVID-19). Indian Journal of
Clinical Biochemistry. 2020 Aug 13:1-2.

Source:Das SK. The pathophysiology, diagnosis and treatment of corona virus disease 2019 (COVID-19). Indian
Journal of Clinical Biochemistry. 2020 Aug 13:1-2.

 Vaccine: A product that stimulates a person’s immune system to produce
immunity to a specific disease, protecting the person from that disease. Vaccines
are usually administered through needle injections, but can also be administered
by mouth or sprayed into the nose.
 Virus vaccines :
These vaccines use the virus itself in a weakened or inactivated form.
Vaccines against measles and polio (oral) are made in this manner. There are two
types of virus vaccines under development against coronavirus, weakened virus
and inactivated virus vaccines
 Viral-vector vaccines :
a virus (such as adenovirus or measles), is genetically engineered to produce
coronavirus proteins in the body, but the virus is weakened and cannot cause
disease. Two types of viral-vector vaccines under development are replicating
viral vector (can replicate within cells) and non-replicating viral vector (cannot
replicate within cells)

 Nucleic-acid vaccines :
Nucleic acid (DNA or RNA) is inserted into human cells.
These human cells then produce copies of the virus
protein which produces an immune response. Two types of
nucleic-acid vaccines under development are DNA
vaccine and RNA vaccine.
 Protein-based vaccines :
Use virus protein fragments or protein shells which are
injected directly into the body. Two types of protein-based
vaccines being developed against the coronavirus are the
protein subunit vaccines and virus-like particle vaccines

 The whole virion inactivated COVID-19 vaccine
 BBV152 contains a whole virion inactivated SARS-CoV-2
vaccine, which is produced in Vero cells. It is stable at 2 to 8°C
(refrigerated) and is shipped in a ready-to-use liquid formulation
that permits distribution using existing vaccine supply chain
channels.
 BBV152 has a 28-day open vial policy as a unique product
characteristic, thus reducing vaccine wastage by approximately
10-30%.
 Data from 25,800 participants, received vaccine or placebo in a
1:1 ratio showed that the vaccine candidate was well tolerated

 The Phase 3 study enrolled 25,800 participants between 18-98 years of age,
including 2,433 over the age of 60 and 4,500 with comorbidities.
 The primary endpoint of Phase 3 clinical trial is based on the first occurrence of
PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at
least 14 days after the second study vaccination in serologically negative (to SARS-
CoV-2) adult participants at baseline.
 The first interim analysis is based on 43 cases, of which 36 cases of COVID-19
were observed in the placebo group versus 7 cases observed in the BBV152
(COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6%.
 The interim analysis included a preliminary review of the safety database, which
showed that severe, serious, and medically attended adverse events occurred at low
levels and were balanced between vaccine and placebo groups.

 History of severe allergic reaction to any
ingredients of the vaccine
 Had a severe allergic reaction after a previous
dose of this vaccine.
 Currently have an acute infection or fever
 Safety of covaxin in pregnancy and lactation:
pregnant or lactating mother should not get the
vaccine as the effect of the vaccine has not been
studied in pregnant women and nursing mothers.

 Individuals on stable anticoagulation therapy whose latest INR was
below the upper threshold of their therapeutic range, can receive
intramuscular vaccination.
 Individuals on Aspirin and/or clopidogrel who have a stable medical
disease condition assessed by the vaccination provider may receive
intramuscular vaccination.
 Individuals with a history of severe allergic reactions NOT related to
vaccines or injectable medications such as environmental allergies,
allergies to food, pet dander, venom, or latex - may still get
vaccinated.
 Individuals with a history of allergies to oral medications or a family
history of allergic reactions, or who might have a mild allergy to
vaccines (but no anaphylaxis) may still get vaccinated.

 Individuals with HIV infection or other immunocompromising
conditions, or who take immunosuppressive medications or
therapies might be at increased risk for severe COVID-19.
However, data is NOT currently available to establish vaccine
safety and efficacy in these groups.
 Individuals with immunosuppression may not generate a full
immune response to COVID-19.
 Transplant recipients should be counselled that the vaccine's
effectiveness and safety profile for them is not currently known. As
it is not a live virus vaccine, it is unlikely to pose a safety risk
 Immunocompromised individuals may receive COVID-19
vaccination if they have no contraindications to vaccination.

 Also known as ChAdOx1 and CoV -19 Corona Virus vaccine
 It is adenoviral vaccine developed in the UK by Jennifer institute,
University of Oxford - as Oxford – AstraZeneca Vaccine .
 On 30 December 2020 the vaccine was approved for use in the UK’s
vaccination program and the first vaccination was administered on 4
January 2021.
 Manufactured in India by Serum Institute of India, Pune.
 It has been given license for restricted use in an emergency situation
for 18 years and above
 In India, Covishield was authorized for use on 3rd January 2021

 Components:
L-Histidine, L-Histidine hydrochloride monohydrate,
Magnesium chloride hexahydrate, Polysorbate 80,
Ethanol, Sucrose, Sodium chloride, Disodium edetate
dihydrate (EDTA), Water for injection .
 Dose: 0.5ml
 1 vial = 5ml (10 doses)
 Route of administration: Intramuscular (IM) in deltoid
 Schedule: 2 doses 4 – 6 weeks apart
 Some studies have shown efficacy if 12 weeks apart
 Storage: 2°C to 8°C
 Shelf life: 6 months

 In some international clinical trails initially half
then full dose vaccine have shown 90%
effectiveness but there is not enough data as
evidence .
 Some data suggests leaving a longer duration
between the 1st and 2nd dose of the vaccine
increases the overall effectiveness (~70%).
 Serum institute of India (SII) has stated that the
vaccine is “highly effective” which is supported
by phase III data from Brazil and UK.

 First issued 10 February 2021 ,Updated 21 April 2021
 Based on the phase 3 trials in the United Kingdom, Brazil and South
Africa, the ChAdOx1-S vaccine has an efficacy of 63% against
symptomatic SARS-CoV-2 infection, as shown by the primary analysis of
data irrespective of interdose interval from trial participants who received
2 standard doses with an interval of about 4 to 12 weeks.
 Vaccine efficacy tended to be higher when the interval between doses was
longer. This, together with the finding of higher antibody levels with
increasing interdose interval, supports the conclusion that longer dose
intervals within the 4–12 weeks range are associated with greater vaccine
efficacy.
 No vaccinated persons were hospitalized as from 22 days after dose 1,
compared with 14 unvaccinated persons who were hospitalized for
COVID-19 in the same time frame. At the time of analysis, the median
follow-up time after the second dose was 80 days.

 The primary analysis included events from 15
days post second dose, with an interdose
interval of 28 days.
 The vaccine efficacy against symptomatic
SARS-CoV-2 infection was 76% (95% CI:
68–82%).
 No severe or critically ill cases occurred in
the vaccinated group; 8 cases occurred in the
placebo group

 Currently, it is recommended that both doses
should be administered with same vaccine
 Studies are underway to assess whether
COVID-19 vaccines using a different platform
can be used interchangeably in the dosing
schedule.

 There should be a minimum interval of 14
days between administration of ChAdOx1-S
[recombinant] vaccine and any other vaccine
against other conditions.

 Preliminary reproductive toxicity studies in mice have not shown
harmful effects of the vaccine in pregnancy. ChAdOx1-S
[recombinant] vaccine is a replication-defective vaccine.
 While available data on vaccination of pregnant women are
insufficient to assess vaccine efficacy or vaccine-associated risks
in pregnancy, studies in pregnant women are planned in the
coming months.
 WHO recommends the use of ChAdOx1-S [recombinant]
vaccine in pregnant women only if the benefits of vaccination
to the pregnant woman outweigh the potential risks.

 a lactating woman who is part of a group
recommended for vaccination according to the
WHO Prioritization Roadmap, e.g. health
workers, should be offered vaccination on
an equivalent basis. WHO does not
recommend discontinuing breastfeeding
after vaccination.
 persons living with HIV who are part of a
group recommended for vaccination may be
vaccinated.

 Persons with acute PCR-confirmed COVID-19
should not be vaccinated until after they have
recovered from acute illness and the criteria for
discontinuation of isolation have been met. The
optimal minimum interval between a natural infection
and vaccination is not yet known.
 Persons who received monoclonal antibodies or
convalescent plasma as part of COVID-19 treatment.
WHO recommends that vaccination should be
deferred for at least 90 days to avoid interference of
the antibody treatment with vaccine-induced immune
responses.

 Preliminary analyses have shown a slightly reduced vaccine effectiveness
of ChAdOx1-S vaccine against B1.1.1.7 in the V002 trial in the United
Kingdom which is associated with only a limited reduction in neutralizing
antibody.
 Preliminary analyses from the phase 1/2a trial (COV005) in South Africa
indicate marked reduction in vaccine effectiveness against mild and
moderate disease due to B 1.351 based on a small sample size and
substantial loss of neutralizing antibody activity.
 This study was designed to assess efficacy against disease of any severity,
but the small sample size did not allow a specific assessment of vaccine
efficacy against severe COVID-19. Indirect evidence is compatible with
protection against severe COVID-19; however, this remains to be
demonstrated in ongoing clinical trials and post-implementation
evaluations.

 The development and use of mRNA vaccines is relatively
new.
 These vaccines consist of messenger RNA(mRNA)
encapsulated by a lipid nanoparticle (LNP) for delivery into
the host cells.
 These vaccines utilize the body’s own cells to generate the
coronavirus spike protein (the relevant antigens), which,
similar to all other vaccines, stimulates immune cells to
create antibodies against COVID-19.
 The mRNA vaccines are not live virus vaccines, nor do
they use an adjuvant to enhance vaccine efficacy.

 These vaccines do not enter the nucleus and do
not alter human DNA in vaccine recipients as a
result, mRNA vaccines cannot cause any genetic
changes (CDC).
 Based on the mechanism of action of these
vaccines and the demonstrated safety and
efficacy in Phase II and Phase III clinical trials, it
is expected that the safety and efficacy profile of
the vaccine for pregnant individuals would be
similar to that observed in non-pregnant
individuals.

 The estimated effectiveness of the vaccine against any
documented infection with the B.1.1.7 variant was 89.5%.
 The effectiveness against any documented infection with the
B.1.351 variant was 75.0%
 Vaccine effectiveness against severe, critical, or fatal disease due
to infection with any SARS-CoV-2 (with the B.1.1.7 and B.1.351
variants being predominant within Qatar) was very high, at
97.4%.
 Nevertheless, the reduced protection against infection with the
B.1.351 variant did not seem to translate into poor protection
against the most severe forms of infection

 Pregnancy
 Cancer
 Chronic kidney disease
 COPD (chronic obstructive pulmonary disease)
 Down Syndrome
 Heart conditions, such as heart failure, coronary artery disease, or
cardiomyopathies
 Immunocompromised state (weakened immune system) from solid
organ transplant
 Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40
kg/m2)
 Severe Obesity (BMI ≥ 40 kg/m2)
 Sickle cell disease
 Smoking (current or history)
 Type 2 diabetes mellitus

 On December 19, 2020, the CDC and ACIP (
advisory committee on immunization practices
)released a statement supporting the
administration of both EUA-approved vaccines to
prevent COVID-19 in persons aged 16 and 18
years, respectively starting with prioritization
groups outlined by the ACIP.
 The CDC, ACOG, SMFM, and other agencies
support offering vaccination to pregnant and
lactating women in these prioritized groups.

 Women who meet criteria for vaccination and are planning to
become pregnant should be encouraged to complete the 2-dose
vaccine before pregnancy.
 Doing so will afford them maximal protection once they become
pregnant.
 If an individual becomes pregnant after the first dose of a COVID-
19 vaccine requiring two doses (Pfizer-BioNtech or Moderna), the
second dose should be administered as indicated.
 If an individual receives a COVID-19 vaccine and becomes
pregnant within 30 days of receipt of the vaccine, participation in
CDC’sv-safe program should be encouraged

 Since vaccines contain mRNA encapsulated
in a lipid nanoparticle that is delivered into
host cells there is no biological reason to
suspect that this process is different during
pregnancy, so similar efficacy is expected in
pregnant and non pregnant persons.
 Second, these vaccines contain no live virus or
adjuvants that could affect the developing
fetus.

 The CDC and the independent Advisory
Committee on Immunization Practices
(ACIP) position on the Pfizer- BioNTech and
Moderna COVID-19 vaccines is that pregnant
women included in the current phase I groups
recommended to receive the vaccine
(e.g.,health care workers) should make a
personal decision about receiving the vaccine.

 For the mRNA COVID-19 vaccines:
A history of a severe allergic reaction, such as
anaphylaxis, after a previous dose of an
mRNA COVID-19 vaccine or to any of its
components (including polyethylene glycol).

 SARS-CoV-2-specific antibodies and cell-
mediated responses are induced following
infection. Evidence suggests that some of these
responses are protective and generally last at least
several months. However, it is unknown whether
all infected patients mount a protective immune
response and how long protective effects last
beyond the first few months after infection.
 The short-term risk of reinfection (eg, within the
first few months after initial infection) appears
low, though reinfection does occur sporadically

 BNT162b2 (Pfizer-BioNTech COVID-19 vaccine) had 95
percent efficacy in preventing symptomatic COVID-19 at or
after day 7 following completion of a two-dose series.
 mRNA-1273 (Moderna COVID-19 vaccine) had 95 percent
efficacy in preventing symptomatic COVID-19 at or after day 7
following completion of a two-dose series.
 Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine)
had 66 percent efficacy against moderate to severe COVID-19
and 85 percent efficacy against severe COVID-19 at or after 28
days following administration of a single dose.

 ChAdOx1 nCoV-19/AZD1222 (AstraZeneca
COVID-19 vaccine) had 70 percent efficacy in
preventing symptomatic COVID-19 at or after
two weeks following completion of a two-dose
series.
 Ongoing evaluation is needed to answer
outstanding questions about efficacy, safety, the
durability of vaccine-induced immunity, and
impact on community transmission. Available
data and the efficacy of other vaccines types are
discussed separately.

 Limited data suggest that certain vaccines can
reduce the risk of asymptomatic infection,
although the overall impact is uncertain.
Because asymptomatic infection contributes to
SARS-CoV-2 transmission, continued
personal and public health preventive
measures are recommended for vaccinated
individuals.

 Many circulating SARS-CoV-2 variants contain mutations
in the surface spike protein, which is the most common
vaccine target. The impact of these mutations on vaccine
efficacy is not well studied and undoubtedly varies by
variant and by vaccine type.
 Preliminary evidence suggests that both BNT162b2 (Pfizer-
BioNTech COVID-19 vaccine) and mRNA-1273 (Moderna
COVID-19 vaccine) retain neutralizing activity against
B.1.1.7, the dominant viral variant in the United Kingdom
and other countries. Both vaccines have reduced
neutralizing activity against B.1.351, the dominant variant
in South Africa, though the clinical significance of this
reduction is not known.

 The efficacy of Ad26.COV2.S (Janssen/Johnson & Johnson
COVID-19 vaccine) varied by region: 74 percent in the United
States, 66 percent in Brazil, where the P.2 variant was prevalent,
and 52 percent in South Africa, where most infections were
caused by the variant B.1.351. Nevertheless, vaccine efficacy
against severe/critical disease was similar across regions.
 The efficacy of ChAdOx1 nCoV-19/AZD1222 (AstraZeneca
COVID-19 vaccine) against B.1.1.7 appears to be similar to wild-
type virus despite reduced neutralizing activity.
 As mutations continue to accumulate, there is potential for
vaccine efficacy to further decline.

 local injection site reactions,
 fever,
 headache,
 fatigue,
 chills,
 myalgias,
 arthralgia
Reactions are more common in younger
individuals and after the second dose.

 Because of the rarity of these events and the
potential severity of COVID-19, the overall
benefits of the vaccines likely outweigh this risk.
 Extremely rare cases of thrombotic events
associated with thrombocytopenia (eg, cerebral
venous sinus thrombosis) have been reported
following vaccination with ChAdOx1 nCoV-
19/AZD1222 (AstraZeneca COVID-19 vaccine)
and Ad26.COV2.S (Janssen/Johnson & Johnson
COVID-19 vaccine)

 Vaccination for COVID-19 is also not a
contraindication to blood donation.
 Individuals who have received an mRNA vaccine
or other non-infectious vaccine (nonreplicating,
inactivated) can donate immediately
 Those who have received a live-attenuated viral
vaccine (and those who are unsure which vaccine
they received) should refrain from donating blood
for a short waiting period (eg, 14 days) after
receiving the vaccine.

 1)The pathophysiology, diagnosis and treatment of corona virus disease 2019 (COVID-19).
Indian Journal of Clinical Biochemistry. 2020 Aug 13:1-2.
 2) Interim guidance for the use of the Astra Zeneca – Oxford University AZD1222 vaccine
against Covid-19. Version 10 February 2021.
 3) covaxin-phase3-clinical-trials-interim-results.
https://www.bharatbiotech.com/images/press/covaxin-phase3-clinical-trials-interim-
results.pdf
 4) Madhi SA, Baillie V, Cutland CL,Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K,
Barnabas SL, Bhorat QE, Briner C. Efficacy of the ChAdOx1 nCoV-19 Covid-19 vaccine
against the B. 1.351 variant. New England Journal of Medicine. 2021 Mar 16.

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