What is happening now in this pandemic, don't need an explanation, and probably will never gonna get it till be too late. Our governments are doing their best in their knowledge to support us, in all directions. I get paid to stay at home with my kids, and before as was working as a key worker, and is very scary to think that you will be going out to bring food to your table, save lives, but you can bring home a deadly virus. The dear and loved health professionals, and carers, the amazing teachers and school workers, the lady Diana from the corner shop, the pizza delivery man, or and numerous professionals, that without wanting are still out there, making our life "normal", and creating the basic conditions for each one of us have the sensation of security, and basic sustainability. Is not a question of is real or not, because people are dying, love ones, families, that cannot even say their goodbyes. For the ones that think this is a conspiracy, I have been there no judgment, we all as humans like to have a reasonable explanation about things, but if I ask them even if it is a conspiration, as an example if they would expose their mothers or your kids to this risk of getting the virus to prove it? The answer first with a moment in silence and the answer is always a big No. If people are kin to put names and tags in things, this is definitely not the moment for it, and dealing with this pandemic with the security that requires, in act responsible to do whatever it takes to save ours, and others lives, is just simple as black and withe. Do your part, stay home, wash your hands, and who knows me will tell you that I can even go further on how hygiene plays an important part in protecting us from diseases. Distancing, and masks are just what is asked to protect yourself, and others. People will complain that is affecting the mental health and is going against peoples free will obey all these measures as the lockdown imposed, Ok I don't wanna appear insensible but having to been obligated to be at home, sit on a comfortable sofa, watching Netflix all day, asking for takeaways, and getting fat. Feeling depressive, complaining out loud, " Way I have to educate, teach, and take care of my own kid till this is over? " Because literally are your own responsibility, that is given with a chance of isolate of a deadly situation, but, not having to hide in caves, but instead enjoy of being at home. That just as a note, the majority are been asking the Universe, " Please I would like to don't have to do nothing, and just be lazy." There you go, the Universe response can be funny. Then pick this opportunity to reinvent yourself, your life, and for the first time in ages, really getting to expend all the time with your kids. Hey, I am not telling will be easy, as a society, as we know, make us used to get help with the means to cope with a very difficult and intricated form of living. But now is gone, and in my personal view, and believe me, I am a very positive thinker, is gone. Then these little persons, that have so much energy and questions will be part of our close daily lives. Learn to deal with it, maybe all will have to change but will change for the better, and we all have to learn to re-adapt, As, like the example of my David Primary school, that is been amazing in supporting us, and they just decided to do a mental health week, given an opportunity to parents and children to relax, and enjoy a week with different kinds of wellbeing activities guided by the school. fantastic or not. This means that at some point will have to be responsible for our sanity, and the ones that are next to us, using all means, including being very creative, innovative, and learn to use inspirations to turn a very difficult, and unusual situation into a positive lesson on how the human race can overcome adversity. But to irradicate global diseases like this is a need of a global vaccination, to ensure you are all protected, and reduce deaths as a cause.
As the title indicates, take the vaccine, and I will let you know that if you have any doubt, do your research. I had to do mine, I didn't want to take the vaccine with doubt. The questions and gossips about these vaccines implicating that was made to work with our genetic, or DNA made me want to know all the story behind this, and also I felt that all the details about the composition of the vaccines were not in any way explained, but please make your own research, check the links that I used as sources, and they are in the bottom os this page, as this a very delicate subject, don't go just for my words.
Then what I understood was that scientists been researching for decades how to modify our DNA molecules to be able to take out of it, or achieve a total cure, of certain very debilitating and incurable diseases, like cancer, or other genetic degeneration. But the problem was that our DNA combination is so intricated that the danger was if touched or move it could bring unimaginable consequences. This incertain was a cause of the cessation of the idea till the discovery of a bacteria that just can be found near to very saline seas, that is called CRISPR, this made all the difference, when after a very deeply investigations scientists come to a conclusion that first, bacterias function is to combat the virus in our natural environment, second that this special CRISPR had the unique DNA structure that would repeat in sequence, not as anything seen before. Instead of ours normal DNA, this one also creates cuts in DNA segments or spaces. This was a blast as the principal dilemma in a specific section in the DNA so delicate structure can now be found a solution in studying this new bacteria.
Now the best part of it, is that after studies what was revealed is that bacteria CRISPR WAS USING MEMORY, TO STORE INFORMATION ABOUT TE ENCOUNTER WITH the virus, and after copying the DNA of the virus was implanting this is in the bacteria DNA, TO BE USED FOR THE NEXT EXPOSURE TO IDENTIFY WITH THE use of one precious antibody, called Cas 9, check, confirm, and destroy the virus in next encounter. All this was amazing in preventing viruses but now was also possible to given direct instruction to the antibody Cas9 that will allow reprogramming any molecular information, reprogramming human, animal, or plants.
This is the definition of what means (mRNA) by Wikipedia.
In molecular biology, messenger RNA (mRNA) is a single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and is read by a ribosome in the process of synthesizing a protein.
Transcription is the process of copying a gene from the DNA into mRNA. This process is slightly different in eukaryotes and prokaryotes, including that prokaryotic RNA polymerase associates with DNA-processing enzymes during transcription so that processing can proceed during transcription. Therefore, this causes the new mRNA strand to become double-stranded by producing a complementary strand known as the transfer RNA (tRNA) strand. In addition, the RNA is unable to form structures from base-pairing. Moreover, the template for mRNA is the complementary strand of tRNA, which is identical in sequence to the anticodon sequence that the DNA binds to. The short-lived, unprocessed, or partially processed product is termed precursor mRNA or pre-mRNA; once completely processed, it is termed mature mRNA.
Hope this brings light and at least now you can understand this is beyond all that we can even understand as news, and discoveries, but the information is out there available you just have to search for it. This is not just a new way of vaccination that will be efficient against this pandemic, but probably, a great answer for future pandemics, and I believe that this is the greatest discovery of our mankind, that will make that our lives will never be the same. Will help cure an immensity of diseases, and perhaps heaven our environmental issues. Then the vaccines that are using this technique is not just secure, but also an open door to the salvation of humanity. After chequing, all the facts is also considered that the use of this new information will question, how we should manipulate our DNA, but I think, that we all can deal with this when we win this pandemic, for now, use it, and save your life, to have a future.
BELIEVE, is my dream of bringing people a new way of life that is in finding harmony within our selves, but I had to believe in this and act on it, then please don't let the negativity of the news, the prospect of a glume future, close your hearths and minds, or putt your down or depressed, no one is alone, we are in this together, and instead of seeing this as the end, try to see this as the beginning of a new age, with the beauty that for the first time in your lives we can choose exactly our experience, learning to redirect our power of the collective mind in a positive way, to shape a better future.
If you feel that you cannot do anything, at least remember that you can take care of yourself, and taking care of how you feel, how you smile, how you react or control your thoughts is empowerment.
Be happy, be positive, be smart. be loving, be special, be vaccinated, and take care.
Them as you know right now is more choices in vaccines appearing, this a very detailed list of information of the ones till date.
The Pfizer-BioNTech
Name of the medicinal product
COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection
Qualitative and quantitative composition
This is a multidose vial and must be diluted before use. 1 vial (0.45 ml) contains 6 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles), see section 4.2.
COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5’-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
Excipients with known effect: For the full list of excipients, see section 6.1.
Pharmaceutical form
Concentrate for solution for injection.
The vaccine is a white to off-white frozen solution.
Clinical particulars
Therapeutic indications
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.
Posology and method of administration
Posology
Individuals 16 years of age and older:
COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) at least 21 days apart (see section 5.1).
There are no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 mRNA Vaccine BNT162b2 should receive a second dose of COVID-19 mRNA Vaccine BNT162b2 to complete the vaccination series.
Individuals may not be maximally protected until at least 7 days after their second dose of the vaccine.
Paediatric population
The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age have not yet been established.
Method of administration
Administer the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle after dilution.
After dilution, vials of COVID-19 mRNA Vaccine BNT162b2 contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Preparation: The multidose vial is stored frozen and must be thawed prior to dilution
Frozen vials should be transferred to 2 °C to 8 °C to thaw. Alternatively, frozen vials may also be thawed and kept at temperatures up to 25 °C for a maximum of two hours in preparation for dilution for use.
When removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 5 days (120 hours) at 2 °C to 8 °C, and an additional 2 hours at temperatures up to 25 °C in preparation for dilution.
When the thawed vial is at room temperature gently invert 10 times prior to dilution. Do not shake. Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. This diluent is not provided in the vaccine carton.
Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
Gently invert the diluted solution 10 times. Do not shake.
The diluted vaccine should present as an off-white solution with no particulates visible. Discard the diluted vaccine if particulates or discoloration are present.
The diluted vials should be marked with the dilution date and time and stored between 2 °C to 25 °C.
Use as soon as practically possible, and within 6 hours after dilution.
After dilution, the vial contains 6 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle and syringe and administer.
Low dead volume syringes and/or needles should be used in order to extract 6 doses from a single vial.
If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Any unused vaccine should be discarded 6 hours after dilution.
After dilution, the vaccine should not be shipped (transported) by motor vehicle away from the site of dilution. Any shipping (transportation) by motor vehicle after dilution of the vial is at the risk of the Health Care Professional.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of the COVID-19 mRNA Vaccine BNT162b2.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
General recommendations
The administration of COVID-19 mRNA Vaccine BNT162b2 should be postponed in individuals suffering from acute severe febrile illness.
Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection, should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.
As with any vaccine, vaccination with COVID-19 mRNA Vaccine BNT162b2 may not protect all vaccine recipients.
No data are available on the use of COVID-19 mRNA Vaccine BNT162b2 in persons that have previously received a full or partial vaccine series with another COVID-19 vaccine.
Excipient information
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium‑free’.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of COVID-19 mRNA Vaccine BNT162b2 with other vaccines has not been studied (see section 5.1).
Do not mix COVID-19 mRNA Vaccine BNT162b2 with other vaccines/products in the same syringe.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of the COVID-19 mRNA Vaccine BNT162b2in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of the COVID-19 mRNA Vaccine BNT162b2 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7 Effects on ability to drive and use machines
COVID-19 mRNA Vaccine BNT162b2 has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
4.8 Undesirable effects
Summary of safety profile
The safety of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older. In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of COVID19 mRNA Vaccine BNT162b and 21,728 participants 16 years of age or older received placebo. Out of these, at the time of the analysis, 19,067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536 placebo) were evaluated for safety 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2.
Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA Vaccine and those who received placebo. Overall, among the participants who received COVID-19 mRNA Vaccine BNT162b2, 51.5% were male and 48.5% were female, 82.1% were White, 9.6% were Black or African American, 26.1% were Hispanic/Latino, 4.3% were Asian and 0.7% were Native American/Alaskan native.
The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used.
Adverse reactions from clinical studies
Adverse reactions reported in clinical studies are listed in this section per MedDRA system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Blood and lymphatic system disorders
Uncommon: Lymphadenopathy
Immune system disorders
Not Known: Anaphylaxis; hypersensitivity
Nervous system disorders
Very common: Headache
Rare: Acute peripheral facial paralysis
Musculoskeletal and connective tissue disorders
Very common: Arthralgia; myalgia
General disorders and administration site conditions
Very common: Injection-site pain; fatigue; chills; pyrexia
Common: Redness at injection site; injection site swelling
Uncommon: Malaise
Gastrointestinal disorders * Common Nausea
Throughout the safety follow-up period to date, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
Reporting of suspected adverse reactions
If you are concerned about an adverse event, it should be reported on a Yellow card. Reporting forms and information can be found at Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play and include the vaccine brand and batch/Lot number if available.
Alternatively, adverse events of concern in association with Pfizer BioNTech COVID-19 mRNA vaccine BNT 162b2 can be reported to Pfizer Medical Information on 01304 616161 or via Pfizer Safety Reporting.
Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymised form) and dual reporting will create unnecessary.
4.9 Overdose
Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
5. Pharmacodynamic properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03
Mechanism of action
The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARSCoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease.
Efficacy in participants 16 years of age and older
The efficacy of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study 1 enrolled 60 participants, 18 through 55 years of age. Study 2 is a multicentre, placebo-controlled efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19 disease. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). There was no requirement for prophylactic use of paracetamol or analgesics. Influenza vaccines could be administered outside a window ± 14 days of the vaccine doses.
In Study 2, approximately 44,000 participants 12 years of age and older were randomised equally and received 2 doses of COVID-19 mRNA Vaccine or placebo with a planned interval of 21 days. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19 disease.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA BNT162b2 vaccine and those who received placebo. Overall, among the participants who received COVID-19 mRNA vaccine, 51.1% were male and 48.9% were female, 82.8% were White, 8.9% were Black or African American, 26.8% were Hispanic/Latino, 4.5% were Asian and 0.6% were Native American/Alaskan native. 57.2% were aged 16-55 years, 42.6% were aged > 55 years and 21.8% were ≥ 65 years.
Efficacy against COVID-19 disease
At the time of the analysis of Study 2, information presented is based on participants 16 years and older. Participants had been followed for symptomatic COVID-19 disease for at least 2,214 person-years for the COVID-19 mRNA Vaccine and at least 2,222 person-years in the placebo group. There were 8 confirmed COVID-19 cases identified in the COVID-19 mRNA Vaccine group and 162 cases in the placebo group, respectively. In this analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine BNT162b2 from first COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior infection with SARS-CoV-2 was 95.0% (95% credible interval of 90.3% to 97.6%). In participants 65 years of age and older and 75 years of age and older without evidence of prior infections with SARS-CoV-2, efficacy of COVID-19 mRNA Vaccine BNT162b2 was 94.7% (two-sided 95% confidence interval of 66.7% to 99.9%) and 100% (two-sided 95% confidence interval of -13.1% to 100.0%) respectively.
In a separate analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine from first COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior infection with SARS-CoV-2 was 94.6% (95% credible interval of 89.9% to 97.3%).
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk of severe COVID-19 disease (e.g. asthma, BMI ≥ 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).
Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 disease.
Case definition (at least 1 of): fever, new or increased cough, new or increased shortness of breath; chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on a conventional study of repeat dose toxicity.
Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered with the COVID-19 mRNA Vaccine BNT162b2 prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to bodyweight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No data on the COVID-19 mRNA Vaccine BNT162b2 are available on vaccine placental transfer or excretion in milk.
6. Pharmaceutical particulars
6.1 List of excipients
This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159.
ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
1,2-Distearoyl-sn-glycero-3-phosphocholine
cholesterol
potassium chloride
potassium dihydrogen phosphate
sodium chloride
disodium hydrogen phosphate dihydrate
sucrose
water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
6 months at -80 °C to -60 °C.
6.4 Special precautions for storage
Store in a freezer at -80 °C to -60 °C.
Store in the thermal container at -90 ºC to -60 ºC.
Store in the original package in order to protect from light.
Once removed from the freezer, the undiluted vaccine can be stored for up to 5 days at 2 °C to 8 °C, and up to 2 hours at temperatures up to 25 °C, prior to use. During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions.
After dilution, store the vaccine at 2 °C to 25 °C and use as soon as practically possible and within 6 hours. The vaccine does not contain a preservative. Discard any unused vaccine.
Once diluted, the vials should be marked with the dilution time and discarded within 6 hours of dilution.
Once thawed, the vaccine cannot be re-frozen.
6.5 Nature and contents of container
Concentrate for solution for injection for 6 doses in a 2 mL clear vial (type I glass) with a stopper (bromobutyl) and a flip-off plastic cap with aluminium seal. See section 4.2 for more information.
Pack size: 195 vials
The Pfizer-BioNTech jab - the first given the green light - is being imported from Puurs, Belgium. The Oxford vaccine, meanwhile, is being made in Britain, by two biotech companies: Oxford BioMedica, based in Oxford
COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine AstraZeneca, solution for injection in multidose container
COVID-19 Vaccine (ChAdOx1 S [recombinant])2. Qualitative and quantitative composition
One dose (0.5 ml) contains:
COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp)
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
This product contains genetically modified organisms (GMOs).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
The solution is colourless to slightly brown, clear to slightly opaque and particle free with a pH of 6.6.
4. Clinical particulars
4.1 Therapeutic indications
COVID-19 Vaccine AstraZeneca is indicated for active immunisation of individuals ≥18 years old for the prevention of coronavirus disease 2019 (COVID-19).
The use of COVID-19 Vaccine AstraZeneca should be in accordance with official guidance.
4.2 Posology and method of administration
Posology
The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks after the first dose (see section 5.1).
It is recommended that individuals who receive a first dose of COVID-19 Vaccine AstraZeneca complete the vaccination course with COVID-19 Vaccine AstraZeneca (see section 4.4).
Elderly population
Efficacy and safety data are currently limited in individuals ≥65 years of age (see sections 4.8 and 5.1). No dosage adjustment is required.
Paediatric population
The safety and efficacy of COVID-19 Vaccine AstraZeneca in children and adolescents (aged <18 years old) have not yet been established. No data are available.
Method of administration
COVID-19 Vaccine AstraZeneca is for intramuscular (IM) injection only, preferably in the deltoid muscle.
For instructions on administration, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded
.
Hypersensitivity
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Concurrent illness
As with other vaccines, administration of COVID-19 Vaccine AstraZeneca should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, COVID-19 Vaccine AstraZeneca should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to persons on anticoagulation therapy, because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen.
Duration and level of protection
The duration of protection has not yet been established. As with any vaccine, vaccination with COVID-19 Vaccine AstraZeneca may not protect all vaccine recipients.
Interchangeability
No data are available on the use of COVID-19 Vaccine AstraZeneca in persons that have previously received a full or partial vaccine series with another COVID-19 vaccine.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is considered to be essentially sodium-free.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of COVID-19Vaccine AstraZeneca with other vaccines has not been studied (see section 5.1).
4.6 Fertility, pregnancy and lactation
Pregnancy
There is a limited experience with the use of COVID-19 Vaccine AstraZeneca in pregnant women.
Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetal development, parturition or post natal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established.
Administration of COVID-19 Vaccine AstraZeneca in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
Breastfeeding
It is unknown whether COVID-19 Vaccine AstraZeneca is excreted in human milk.
Fertility
Preliminary animal studies do not indicate direct or indirect harmful effects with respect to fertility.
4.7 Effects on ability to drive and use machines
COVID-19 Vaccine AstraZeneca has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
4.8 Undesirable effects
Summary of the safety profile
The overall safety of COVID-19 Vaccine AstraZeneca is based on an interim analysis of pooled data from four clinical trials conducted in the United Kingdom, Brazil, and South Africa. At the time of analysis, 23,745 participants ≥18 years old had been randomised and received either COVID-19 Vaccine AstraZeneca or control. Out of these, 12,021 received at least one dose of COVID-19 Vaccine AstraZeneca. The median duration of follow-up in the COVID-19 Vaccine AstraZeneca group was 105 days post dose 1, and 62 days post dose 2.
Demographic characteristics were generally similar among participants who received COVID-19 Vaccine AstraZeneca and those who received control. Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 90.3% were aged 18 to 64 years and 9.7% were 65 years of age or older. The majority of recipients were White (75.5%), 10.1% were Black and 3.5% were Asian; 55.8% were female and 44.2% male.
The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. By day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13% respectively. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently.
Adverse reactions were generally milder and reported less frequently in older adults (≥65 years old).
If required, analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used to provide symptomatic relief from post-vaccination adverse reactions.
Tabulated list of adverse reactions
Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Adverse drug reactions
MedDRA SOC: Blood and lymphatic system disorders
Frequency: Uncommon
Adverse reactions: Lymphadenopathy (a)
MedDRA SOC: Metabolism and nutrition disorders
Frequency: Uncommon
Adverse reactions: Decreased appetite (a)
MedDRA SOC: Nervous system disorders
Frequency: Very common
Adverse reactions: Headache
MedDRA SOC: Nervous system disorders
Frequency: Uncommon
Adverse reactions: Dizziness (a)
MedDRA SOC: Gastrointestinal disorders
Frequency: Very common
Adverse reactions: Nausea
MedDRA SOC: Gastrointestinal disorders
Frequency: Common
Adverse reactions: Vomiting
MedDRA SOC: Gastrointestinal disorders
Frequency: Uncommon
Adverse reactions: Abdominal pain (a)
MedDRA SOC: Skin and subcutaneous tissue disorders
Frequency: Uncommon
Adverse reactions: Hyperhidrosis (a), pruritus (a), rash (a)
MedDRA SOC: Musculoskeletal and connective tissue disorders
Frequency: Very common
Adverse reactions: Myalgia, arthralgia
MedDRA SOC: General disorders and administration site conditions
Frequency: Very common
Adverse reactions: Injection site tenderness, injection site pain, injection site warmth, injection site erythema, injection site pruritus, injection site swelling, injection site bruising (b), fatigue, malaise, pyrexia (c), chills
MedDRA SOC: General disorders and administration site conditions
Frequency: Common
Adverse reactions: Injection site induration, influenza like illness (a)
(a) Unsolicited adverse reaction
(b) Injection site bruising includes injection site haematoma (uncommon, unsolicited adverse reaction)
(c) Pyrexia includes feverishness (very common) and fever ≥38°C (common)
Very rare events of neuroinflammatory disorders have been reported following vaccination with COVID-19 Vaccine AstraZeneca. A causal relationship has not been established.name of the medicinal product.
1-COVID-19 Vaccine Moderna dispersion for injection
COVID-19 mRNA Vaccine (nucleoside modified)
2. Qualitative and quantitative composition
This is a multidose vial which contains 10 doses of 0.5 mL.
One dose (0.5 mL) contains 0.10 mg of mRNA (embedded in lipid nanoparticles).
COVID-19 mRNA vaccine is single-stranded, 5’-capped messenger RNA (mRNA) produced using cell-free in vitro transcription, encoding the pre-fusion stabilized Spike (S) glycoprotein of SARS-CoV-2.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Dispersion for injection
White to off-white frozen dispersion (pH: 7.0 – 8.0).
4. Clinical particulars
4.1 Therapeutic indications
COVID-19 Vaccine Moderna is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus in individuals 18 years of age and older.
The use of COVID-19 Vaccine Moderna should be in accordance with official guidance.
4.2 Posology and method of administration
COVID-19 Vaccine Moderna should be administered by a trained healthcare worker.
COVID-19 Vaccine Moderna vials are for multiple use. Each multidose vial contains 10 doses of 0.5 mL.
Posology
Individuals 18 years of age and older:
COVID-19 Vaccine Moderna is a two-dose regimen. Each dose is 0.5 mL. It is recommended to administer the second dose 28 days after the first dose (see section 5.1).
There are no data available on the interchangeability of COVID-19 Vaccine Moderna with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 Vaccine Moderna should receive a second dose of COVID-19 Vaccine Moderna to complete the vaccination series.
Paediatric population
The safety and efficacy of COVID-19 Vaccine Moderna in children and adolescents less than 18 years of age have not yet been established. No data are available.
Method of administration
COVID-19 Vaccine Moderna should only be administered by the intramuscular route. The preferred site is the deltoid muscle of the upper arm.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Anaphylactic reactions
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision to manage immediate allergic reactions must always be readily available in case of an acute anaphylactic reaction following administration of the COVID-19 Vaccine Moderna.
Close observation for at least 15 minutes is recommended following vaccination.
A second dose of COVID-19 Vaccine Moderna should not be given to those who have experienced severe allergic reactions (e.g. anaphylaxis, generalised urticaria) to the first dose of COVID-19 Vaccine Moderna (see section 4.3).
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Immunocompromised individuals
Efficacy, safety and immunogenicity have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COVID-19 Vaccine Moderna may be less in these individuals.
Coagulation disorders
As with other intramuscular injections, COVID-19 Vaccine Moderna should be given with caution in individuals with bleeding disorders, such as haemophilia, or individuals currently on anticoagulant therapy, to avoid the risk of haematoma following the injection.
Acute illness
Immunization should be postponed in individuals with severe febrile illness or severe acute infection. Individuals with moderate or severe acute illness should be vaccinated as soon as the acute illness has improved.
Limitations of vaccine effectiveness
Vaccination with COVID-19 Vaccine Moderna may not protect all vaccine recipients. Individuals may not be fully protected until 14 days after their second dose. The duration of protection afforded by the vaccine is unknown at present. Reference should be made to section 5.1.
Excipients with known effect
Sodium
This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL dose and is essentially ‘sodium-free’
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
There are no data to assess the concomitant administration of COVID-19 Vaccine Moderna with other vaccines (see section 5.1).
4.6 Fertility, pregnancy, and lactation
Pregnancy
There is limited experience with use of COVID-19 Vaccine Moderna in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of COVID-19 Vaccine Moderna in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether COVID-19 Vaccine Moderna is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7 Effects on ability to drive and use machines
No studies on the effects of the COVID-19 Vaccine Moderna on the ability to drive and use machines have been performed.
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
4.8 Undesirable effects
Summary of the safety profile
The safety of COVID-19 Vaccine Moderna was evaluated in an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351 participants 18 years of age and older who received at least one dose of COVID-19 Vaccine Moderna (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older.
The most frequently reported adverse reactions were injection site pain (92%), fatigue (70%), headache (65%), myalgia (62%), arthralgia (46%) chills (46%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after the second dose than after the first dose. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used.
Tabulated list of adverse reactions
The safety profile presented below is based on data generated in a placebo- controlled clinical study of 30,351 adults ≥ 18 years of age.
Adverse reactions reported are listed according to the following frequency:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse drug reactions (ADRs)
System Organ Class: Blood and lymphatic system disorders
Frequency: Very common
Adverse reactions: Lymphadenopathy
Lymphadenopathy was captured as axillary swelling/tenderness on the same side as the injection site.
System Organ Class: Immune system disorders
Frequency: Not known (cannot be estimated from the available data)
Adverse reactions: Anaphylaxis
Anaphylaxis has been reported in the post-marketing setting.
System Organ Class: Immune system disorders
Frequency: Not known (cannot be estimated from the available data)
Adverse reactions: Hypersensitivity.
System Organ Class: Nervous system disorders
Frequency: Very common
Adverse reactions: Headache.
System Organ Class: Nervous system disorders
Frequency: Rare
Adverse reactions: Facial paralysis
Throughout the safety follow-up period, acute peripheral facial paralysis (or palsy) was reported by three participants in the COVID-19 mRNA Vaccine group and one participant in the placebo group. Onset in the vaccine group participants was 22 days, 28 days, and 32 days after Dose 2.
System Organ Class: Gastrointestinal disorders
Frequency: Very common
Adverse reactions: Nausea, Vomiting.
System Organ Class: Subcutaneous and skin disorders
Frequency: Common
Adverse reactions: Rash
System Organ Class: Musculoskeletal and connective tissue disorders
Frequency: Very common
Adverse reactions: Myalgia, Arthralgia
How does the Johnson & Johnson vaccine work?
Johnson & Johnson, which owns the pharmaceutical firm Janssen, has announced clinical data from its Phase 3 study into a Covid-19 vaccine.
– What do the results show?
The vaccine is 66% effective at preventing moderate to severe Covid-19 but offers high protection against people needing to go to the hospital.
Johnson & Johnson said the jab was 85% effective in preventing severe disease “and demonstrated complete protection against Covid-19 related hospitalization and death as of day 28”.
– What else is exciting?
A major advantage of the J&J vaccine is that it can be given as a single dose.
This means it can be rolled out across populations much more quickly than two-dose vaccines.
Another major advantage is that it does not require ultra-cold storage like the jabs from Moderna and Pfizer. It can be kept at fridge temperature for at least three months.
The UK has struck a deal for 30 million doses of the vaccine, with the option of ordering 22 million more.
– How does the vaccine work?
Unlike the mRNA vaccines from Moderna and Pfizer, the J&J vaccine uses an adenovirus – a type of virus that causes the common cold – which has been modified so it cannot replicate and cause illness.
This is very similar to the approach used by Oxford University and AstraZeneca, which have also used an adenovirus.
We already know that the Covid-19 virus is studded with spike proteins that it uses to enter human cells – these spike proteins are the target for vaccines.
The J&J vaccine is based on the virus’s genetic instructions for building the spike protein and uses double-stranded DNA.
The gene for the coronavirus spike protein has been added to the adenovirus. Following injection, this genetic material is read by the body’s cells to mount an immune response to the perceived threat.
If, later on, the vaccinated person comes into contact with the virus, the immune system is prepared to attack it.
Antibodies and immune cells work together to kill the virus, prevent its entry into the body’s cells and destroy any cells that are infected.
– Has this technology been used before?
Yes, J&J has used this technology before in an Ebola vaccine and in investigational vaccines for HIV, both of which have accrued long-term safety data.
Experts believe the immune system contains special cells called memory B cells and memory T cells which might retain information about the coronavirus for a long time.
Scientists in the UK expect coronavirus vaccines to become an annual jab, with yearly modifications to adapt to different strains of the virus.
Sources:
Human Nature Documentary in Netflix directed by Adam Bolt, Writers, Adam Bolt, and Regina Sobel
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca
Belfast Telegraph
https://www.belfasttelegraph.co.uk/news/uk/how-does-the-johnson-and-johnson-vaccine-work-40026704.html
https://en.wikipedia.org/wiki/Messenger_RNA
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