Dear readerThe novel coronavirus disease (covid-19)lockdown has led to disruptions on a scale wehave never seen before. It is not clear how thenew normal of our lives will be. we are livingin unprecedented times the covid-19 pandemichas profoundly changed our personal andprofessional lives. The national push to getpeople vaccinated against covid-19 representsan arms race – the faster the shots arrive inarms, the closer we are to reopening society.Regarding vaccination many apprehensionsexisting among public have to be removed andknowledge on this will lead to betterfunctioning of the society.

Chief Patron:

Sri B.S. Appa Rao

Patron:

Sri B. S. Sri Krishna

ADVISORY COMMITTEE

Dr. S. Satyanarayana

Retd. Professor, Andhra University

Mr. A. V. Krishna Raju

Scientist,

Laila Impex, Vijayawada

Dr. K. Vijaya Sekhar

Professor, Govt. Gen. Hospital, Guntur

Dr. Sankar

Govt. Gen. Hospital, Vijayawada

EDITORIAL BOARD

Editor-in-chief :

Dr. K. Padmalatha

Principal, VIPW

Editorial Members

Mr. D. Santhi Krupa

Mr. Y. Naveen

Dr. N. Prathibha

Dr. M. Tabitha Sharon

Dr. B. Dhanush

Mrs. V. V. Vandana

Student Co-ordinators

Nallala Vara Lakshmi

Pasupuleti Neelima

N. Jaya Sree

M. Bharathi

P. Pushpa Latha

K. Sai Sudha

Sk. Vaseem

Hema Sri Dendukuri

T. Sirisha

Naga Kalyani Durga

P. Surekha

The Coronavirus Disease 2019 (COVID-19)pandemic has presented a major threat to publichealth worldwide alongside unprecedented globaleconomic and social implications. In the absenceof a "gold standard" treatment, the rapiddevelopment of a safe and effective vaccine isconsidered the most promising way to control thepandemic. Over 200 COVID-19 vaccine varietiesare under trails worldwide. Vaccine developmenttargeting the SARS-CoV-2 virus poses severalchallenges. The following are the vaccine varitiescurrently under development or authorized foremergency use to reduce infection associated withSARS-CoV-2.

Messenger RNA VaccinesVaccines with the greatest potential for rapiddevelopment are RNA-based platforms. Pfizer-BioNTech (BNT162b2) Comirnaty®(tozinameran) and Moderna (mRNA-1273) arenewly developed mRNA vaccines. These vaccinesfunction on the premise that mRNA coded forpathogen antigen can be delivered into human cellsand result in production of antigen within the cell.Unlike other vaccines, this triggers an immuneresponse without the introduction of live, killed,or subunit portions of the virus. The mRNA cannotcause infection, does not alter human DNA, and isbroken down by normal processes in human cells.One of the main concerns of utilizing mRNA-basedplatforms is the potential of synthetically

formulated mRNA to cause a severe adversereaction due to its inherent inflammatory nature.In addition, mRNA is highly susceptible to extracellular ribonucleases and is rapidly degraded, soit must be encapsulated in a protective lipid systemto facilitate delivery into human cells. BecausemRNA is naturally unstable, it must be stored infrozen form below -20 °C, which complicates theshipping, storage, and administration of mRNAvaccines.

Viral Vector VaccinesTwo SARS-CoV-2 vaccines Astra Zeneca Oxford(AZD1222), Janssen/Johnson & Johnson(Ad26.COV2-S) under development usenonreplicating viral vectors to transportrecombinant SARS-CoV2 spike protein genes intothe human cell. The infected cells display thecoronavirus spike protein on their surfaces, whichstimulate the immune system to develop antibodies.This transient viral DNA protein is not incorporatedinto the host cell DNA. The AstraZeneca vaccineuses a simian adenovirus and the Janssen/Johnson& Johnson vaccine uses a human adenovirus.Because these adenoviruses do not replicate, a highdose is required, producing about 12 hours of flu-like symptoms as the immune system responds tothe vaccine. The Janssen/Johnson & Johnsonvaccine was administered as a single dose in thefirst phase 3 trial. A second phase 3 trial has beenusing 2 doses of the vaccine to evaluate safety andefficacy.

Recombinant Protein-Based Vaccines The Novavax and Sanofi/GlaxoSmithKline (GSK)immunizations include SARS-CoV-2 proteins, butno genetic material. Since this method actuallyproduces a unique protein, it is harder tomanufacture than other vaccines and requires moretime to ensure production meets high -qualitystandards. The proteins are recognized by T-cellsas target antigens, which generate an immuneresponse. The Novavax product has shown efficacyin initial trials. The Sanofi/GSK vaccine has notproduced the desired level of response in subjectsover the age of 50 years.

Conclusion At this time, data are not available to determinehow long the mRNA vaccines will provideprotection, nor is there evidence that these vaccinesprevent transmission of SARS-CoV-2 from personto person.

Source: https://www.gavi.org/vaccineswork/covid-19-vaccine-race

SARS-CoV-2, the virus that causes COVID-19, has had a majorimpact on human health globally; infecting a large number ofpeople; causing severe disease and associated long-term healthcomplications resulting in death and excess mortality, especiallyamong older and vulnerable populations; interrupting routinehealthcare services, disruptions to travel, trade, education andmany other societal functions; and more broadly has a negativeimpact on people’s physical and mental health. Since the startof the COVID-19 pandemic, WHO has received several reportsof unusual public health events possibly due to variants of SARS-CoV-2.

B.1.1.7 lineage (a.k.a. 20I/501Y.V1 Variant of Concern(VOC) 202012/01) :

On 14 December 2020, authorities of the United Kingdomreported to WHO a variant referred to by the United Kingdomas B.1.1.7 or SARS-CoV-2 VOC 202012/01 (Variant of Concern,year 2020, month 12, variant 01) emerged with a large numberof mutations. This variant has since been detected in numerouscountries around the world, including the United States (US).This variant has a mutation in the receptor binding domain(RBD) of the spike protein at position 501, where the aminoacid asparagine (N) has been replaced with tyrosine (Y). Theshorthand for this mutation is N501Y. This variant also hasseveral other mutations, including:

● 69/70 deletion occurs spontaneously many times and likelyleads to a conformational change in the spike protein

● P681H: near the S1/S2 furin cleavage site, a site with highvariability in coronaviruses. This mutation has also emergedspontaneously multiple times.

Preliminary epidemiologic, modelling, phylogenetic and clinicalfindings suggest that SARS-CoV-2 VOC 202012/01 hasincreased transmissibility. However, preliminary analyses alsoindicate that there is no change in disease severity (as measuredby length of hospitalization and 28-day case fatality), oroccurrence of reinfection between variant cases compared toother SARS-CoV-2 viruses circulating in the United Kingdom.This variant is reported in the US at the end of December 2020.

B.1.351 lineage (a.k.a. 20H/501Y.V2):

On 18 December, national authorities in South Africa announcedthe detection of a new variant of SARS-CoV-2 that is rapidlyspreading in three provinces of South Africa. South Africa hasnamed this variant 501Y.V2, because of a N501Y mutation. Thisvariant shares some mutations with B.1.1.7. It has multiplemutations in the spike protein, including K417N, E484K,N501Y.

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SARS-CoV-2 MUTATIONS AND ITS VARIANTS

Source : https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html

Unlike the B.1.1.7 lineage detected in the UK, this variant doesnot contain the deletion at 69/70. Cases attributed to this varianthave been detected in multiple countries outside of South Africa.The variant is associated with a higher viral load, which maysuggest potential for increased transmissibility, as well as otherfactors that influence transmissibility, are subject of furtherinvestigation. Moreover, at this stage, there is no clear evidenceof the new variant being associated with more severe disease orworse outcomes. Further investigations are needed to understandthe impact on transmission, clinical severity of infection,laboratory diagnostics, therapeutics, vaccines, or public healthpreventive measures.

P.1 lineage (a.k.a. 20J/501Y.V3) :

In Brazil, a variant of SARS-CoV-2 (known as P.1) emergedthat was first was identified in four travelers from Brazil, whowere tested during routine screening at Haneda airport outsideTokyo, Japan. This variant has 17 unique mutations, includingthree in the receptor binding domain of the spike protein. Whilemutations of SARS-CoV-2 are expected, it is important tocontinue to monitor the public health implications of new virusvariants. Any increased in transmissibility associated withSARS-CoV-2 variants could make control more difficult. Currentdisease control measures recommended by WHO continue tobe effective and should be adapted in response to increasingdisease incidence, whether associated with a new variant or not.

Prevention advice and communications for the public shouldbe further strengthened, including precautions to protect oneselfand others such as physical distancing, wearing a mask, keepingrooms well ventilated, avoiding crowds, cleaning hands, andcoughing into a bent elbow or tissue.

A PHARMACY PRACTICE NEWSLETTER (3) Volume 5, Issue 3

TINIDAZOLE

Risk of skin hyper pigmentationThe NCC-PvPI has made a recommen-dation to the CDSCO to request thatthe PIL (Prescribing information leaf-let) for tinidazole is revised to incor-porate skin hyperpigmentation as aclinically significant adverse drug re-action. Tinidazole is used for the treat-ment of amoebiasis and giardiasis inadult patients only and in the treatmentof anaerobic infections. Between July2011 and November 2019, the NCC-PvPI received a total of 13 ICSRs oftinidazole associated skin hyperpig-mentation. The cases were evaluatedby the SRP, PvPI, and IPC who founda strong causal relationship betweentinidazole use and skin hyperpigmen-tation.Reference: Based on the communica-tion from NCC-PvPI, IPC India(ipc.gov.in)

Source : https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020.

REGULATORY NEWSHYDROXYCHLOROQUINE

Risk of prolonged QT, ventriculartachycardiaThe Ministry of Health, Labour and Wel-fare (MHLW) and the Pharmaceuticals andMedical Devices Agency (PMDA) haveannounced that the package insert forhydroxychloroquine (Plaquenil®) shouldbe revised to include prolonged QT andventricular tachycardia as adverse drug re-actions. Hydroxychloroquine is indicatedfor cutaneous lupus erythematosus and sys-temic lupus erythematosus. A total of fourcases of prolonged QT and ventricular ta-chycardia (including torsades de pointes)were reported in patients who usedhydroxychloroquine in Japan during theprevious three years. A causal relationshipbetween the drug and event could not beestablished for any of these cases. One caseof patient mortality has been reported anda causal relationship could not be estab-lished. The MHLW and PMDA have con-cluded that a revision of the package insertis necessary.Reference: Revision of Precautions,MHLW/PMDA, 8 September 2020(www.pmda.go.jp/english/)

DENOSUMABIncreased risk of multiple vertebralfractures The MHRA has announced that the Com-mission on Human Medicines’Pharmacovigilance Expert Advisory Groupsuggested that there is an increased risk ofmultiple vertebral fractures after stoppingdenosumab (Prolia®) for osteoporosis.Denosumab is indicated for treatment of os-teoporosis and bone loss associated withhormone ablation in men with prostate can-cer or with long-term systemic glucocorti-coid therapy in adult patients. From 2015to June 2020, 44 cases of vertebral frac-ture, including multiple fractures, have beenreported in the UK in post-marketing set-tings in patients after stopping or delayingongoing treatment with denosumab. Health-care professionals should evaluate apatient’s individual factors for benefits andrisks before initiating treatment withdenosumab, particularly in patients at in-creased risk of vertebral fractures (e.g. pre-vious vertebral fracture). Patients shouldnot stop denosumab without specialist re-view.Reference: Drug Safety Update, MHRA, 26August 2020 (www.gov.uk/mhra)

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The Editorial Board, A Pharmacy Practice News Letter,Vijaya Institute of Pharmaceutical Sciences for Women (VIPW),Enikepadu, Vijayawada - 521 108, Ph: 0866-6460999.Email: vijayapharmacyfw@gmail.com Website: www.vipw.in

A PHARMACY PRACTICE NEWSLETTER (4) Volume 5, Issue 3

� During lockdown the institution has taken up many activities like social service and participated in awareness program.

� On 24.09.2020 students and staff visited Nirmal hruday bhavan Vijayawada orphanage for the old and sick. They distrib-uted snacks to the inmates of the house.

� During national pharmacy week celebrations i.,e from 16.11.2020 to 23.11.2020 students have created videos Pamphletsand posters to spread awareness on preventive measures of covid-19.

� On 17.11.2020 students visited medical stores in the villages of Ramavarapadu and Nidamanuru to make the pharmacist’srole significance.

� On 18.11.2020 students visited Pratap and Prakash industries in the village of Enikepadu to create awareness on preventivemeasures of covid-19.