Since the virus is mutating very fast, instead of a vaccine to prevent it, we need to put more focus on some sort of medical protocol which would cure us in few days even if we got infected.
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.
Vaccine is the weapon that is going to win the war, .... severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine BNT162b2 (Pfizer/BioNTech) and that of Moderna, as their rollout begins. A great achievement for sure, but this first step in what will need to be a global mass immunisation programme will not immediately end the COVID-19 pandemic. Although control over the infection's most harmful effects is expected and limiting its spread can be hoped for, it will likely be a few years before the virus can be brought under control worldwide. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30226-3/fulltext
Ideally, multiple vaccines will be approved in most countries and we will have a detailed understanding of their efficacy, the duration of the immunity they induce, and their effect on viral transmission. At the time of writing, there have been efficacy reports from phase 3 trials of five vaccines (BNT162b2, mRNA-1273 [Moderna], ChAdOx1 nCoV-19 [University of Oxford and AstraZeneca], Sputnik V [Gamaleya Research Institute], and BBIBP-CorV [Sinopharm]), but the data to support these reports have only been published in peer-reviewed journals for BNT162b2 and ChAdOx1 nCoV-19, and only the former has been evaluated by drug regulatory authorities and approved for emergency or limited use in some countries. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30226-3/fulltext
Vaccines will be instrumental in the control of COVID-19, but their global distribution will be challenging and their effect won't be immediate. As cases and deaths continue to rise across the world, the non-pharmaceutical interventions to constrain the spread of SARS-CoV-2 that the global population has by now become accustomed to will need to remain in place for a while longer. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(20)30226-3/fulltext
The following systems and information sources add an additional layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible:
CDC: V-safe — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys from CDC to check in with vaccine recipients following COVID-19 vaccination. V-safe also provides second vaccine dose reminders if needed, and telephone follow up to anyone who reports medically significant (important) adverse events.
CDC: National Healthcare Safety Network (NHSN) — An acute and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or VAERS that will allow for determination of COVID-19 vaccine adverse event reporting rates.
FDA: Other large insurer/payer databases — A system of administrative and claims-based data for surveillance and research.
Yes, I have to trust the COVID 19 vaccines launched on the market. As per the scientific guidelines these vaccines are develop and I see a lot of Doctors and scientists advocating the safe uses of this vaccines.
For the second part of the answer:
I think it is the only way currently available, but if the mutated new COVID-19 is very different than the COVID-19 then it would be huge challenge to stop this epidemic.
The vaccine is for emergency purposes and it is based on the belief that the fear of known is worth given emergency attention than the fear of unknown. So, it is not to expect 100% efficacy.
There is a difference between 'effectiveness' and 'efficacy'. Been effective in uncompleted trials does not mean that the vaccines will pass the efficacy test. However, the threat of the disease is highly threatening to fold our arms. Saving lives through preventive measures is highly demanding. The questions we are yet to answer are many. Of note, for how long will the protection lapse? Does it mean the vaccinated population will not continue to fuel the contagion?
Laura Bulgariu , great and very important questions.
The preventive mRNA vaccines against infectious diseases had never been tried out in humans -until now. Some therapeutic mRNA concepts (not as a part of infectious diseases preventive vaccines) are however already seen .
Protection Principles: The mRNA vaccines for Covid-19 take advantage of the cellular translation system. Every Shot of BionTech or Moderna vaccine delivers a microscopic, lipophilic package into human organism / human cells, carrying a modified mRNA sequence. The mRNA used in the BionTch/Pfizer Vaccine does not occur in this form in SARS-CoV-2 , but it mimics the prominent immune dominant part of the virus. Lipophilic nano-particles, which prevent mRNA degradation by host RNAse and deliver mRNA into host cells , contains (in the BionTch vaccine): cholesterol, PEG as a part of the PEGylated lipid ALC-0159, Distearoyl-sn-glycero-3-phosphocholine, cationic lipid ALC-0315. To my knowledge, it is the first time that ALC-0315 and ALC-0159 occur as compounds of a disease preventive vaccine and of course, once again, it is the first time a vaccine for an infectious disease prevention purpose contain mRNA and is tried out in humans. After mRNA pass the phospholipid double layer and enters the human cell, it is located in cytoplasm. When that cytosolic mRNA meets up with human ribosomes, they use it to translate RNA bases into AA-sequence that mimics the immunodominant part of SARS-CoV-2 spike protein. Human ribosomes interpret this new mRNA as if it were generated from our own DNA, but the DNA inside the cell’s nucleus will not be exposed to mRNA coding for the part of the S-protein. By immunisation with the modRNA ( BNT162b2) the intention is to trigger a strong and relatively long-lasting production of high affinity virus neutralizing antibodies, which can act through blocking the S-protein and it’s receptor-binding domain (RBD) interaction with host cell receptors, and also by opsonisation mediated virus clearance. The synthesis of useless antibodies has to be ruled out. Because T-cell based immunity has also a prominent role in the successful defense against SARS-CoV-2 Infection, the immunisation with BionTech candidate 162b2 is also intended to elicit a T cell response of the Th1 type, supporting the B cells responsible for the production of S-specific antibodies and cytotoxic T cells that kill virus infected cells. The delivery system showed acceptable efficiency. ALC-0315 serves as the primary driver of delivery. It allows the Lipid-nanoparticles to reach a neutral charge in a physiological environment - this facilitate internalization process.
The hope is, that the produced amino acid sequence will be enough immunogenic to teach the immune system in vivo (in humans) to generate enough neutralizing Immunoglobulins (bNab) which would be able to protect all recipients against the disease. And this is indeed the main goal of SARS-CoV-2 vaccines – to prevent a personal infection. The declared efficiency by BionTech/Pfizer is about 95%. If the further observation confirmed this, it will be a mRNA-SARS-CoV-2 vaccine with an excellent efficiency, no doubt.
BUT ,if this postulated high protection ( "effectiveness of more than 94% consistent across all ages, races and ethnicities ") should be indeed realized in recipients, it doesn’t mean the vaccine can also interrupt the transmission of the virus. That is why the SARS-CoV-2 vaccine engaged countries don’t recommend mask sanctions even after a person received two shots of mRNA vaccine. And of course, there are some important considerations regarding the toxicities associated with the new mRNA BionTech/Pfizer and Moderna vaccine. There are certainly unique, unknown risks to messenger RNA vaccines, including the possibility that they generate anaphylactic reactions and/or strong type I interferon responses that could lead to inflammation and autoimmune conditions. Impurities are further point which have to be ruled out in a vaccine with high safety/ low or (in best cases) negligible toxicity. To know how to effectively target immunodominance will be without any doubt one of the key points in development of effective SARS-CoV-2 vaccine.
It is clear, at this time we have more questions than answers. And I m sure further optimizations of the new vaccine are possible.
In fact, I rather trust the information provided by manufacturers, i.e. pharmaceutical companies, indicating a high level of effectiveness of SARS-CoV-2 (Covid-19) vaccines. However, since there are several producers and perhaps there will be more and the SARS-CoV-2 (Covid-19) coronavirus will mutate and it is not known what new variants of this virus will be in a year, etc., there are still many unanswered questions. It will not be revealed until mid to late 2021 which vaccines have proved to be more effective and whether they are also effective against new variants of the Coronavirus. At the moment, there are still many unanswered questions. However, it is to be hoped that the global problem of the Coronavirus pandemic will be substantially resolved by 2021 with vaccines.
I have my skepticism about the vaccines. First is how scientific procedures were broken to generate vaccines less than a year. Second, no one knows the future side effects of the vaccines and for how long they can be preventive against the virus, especially now that new strains are evovling. Also, how will the vaccines perform in tropical Africa since there are no records of their trials in the region?
I guess we will know how effective they are and their possible side effects in the nearest future. For now, trusting science with caution is the only option.
I am not a medic but I have to say that if I had unlimited resources like they did I could pack 10 years worth of work into a year. The vaccines went through standard clinical trials, just unhindered by beurocratic delays and funding shortfalls. I am surprised by the unscientific responses to this question. A nurse was diagnosed with covid-19 a week after vaccination. That is not surprising. The Phizer vaccine needs time to work and a second dose to be 95% effective. It is still only 95%. The vaccine is not a panacea. People still need to keep distance and wear masks or it will keep spreading.
I do not trust these vaccines, yet I think that this epidemic does not take much time and does not spread. Countries must have a strong health system that allows them to address the risks of various epidemics.
Scientists working there have told us that its credibility level is above 95%! So, I personally feel that it will be effective. But, it might have its own side-effects too. That needs to be seen!
Laura Bulgariu (once again thanks for being author of this important discussion !)
The theoretical level of 95% is the declaration by the company. However, we have always to consider the emerging mutations (in agreement with Sir Dariusz Prokopowicz ).
In the spring 2020, relatively early in the era of recognized SARS-CoV-2 pandemic , the D614G mutation (increases virion spike density and leads to increased infectivity, relative to “wild “type” strains)rapidly became dominant over the “wild-type strain”.And very soon a new mutant was identified in the UK, so called Kent strain (B.1.1.7), and has since November (or likely earlier) spread internationally.There is growing concern over another mutant from South Africa B.1.351 or rather 501.V2 variant, known as 20C/501Y.V2, B.1.351 lineage, which is different compared with the UK-variant (B.1.1.7) and may be able to reinfect people who have previously been infected with and recovered from Covid-19. While the Kent Variant, which does not contain the E484K mutation, will be suspected to could be a variant,which anti-S-protein antibodies induced by currently available mRNA vaccines, will still neutralize quite well, the South African mutant is postulated to could be a concern, since E484K is unlike N501Y able to cause conformational changes in flexible loop region of the RBD and this could lead to escape of the South African 501Y.V2 variant from neutralization by existing anti-SARS-CoV-2 antibodies or via mRNA vaccine induced anti-SARS-CoV-2 antibodies. Here, we can see disadvantages in vaccines whose efficacy is dependent upon humoral responses to the Spike-protein/ antigen. Vaccines whose efficacies depends upon humoral responses to S-, N-protein and M-protein epitopes should be more efficient. I would also like to add the need of potent specific anti-SARS-CoV-2 drugs (like for example Neuraminidase Inhibitors for Influenca A viruses with quite high resistance barrier seen in Zanamivir) available for all people with severe immunodeficiency or other reasons why they should not be vaccinated.... THANKS FOR DISCUSSION and good luck .
To achieve something good, we should always have the trust and faith and work accordingly. Researchers are working day to and night to combat with the disasterous situation, and definetly they will going to make vaccine. And it will have a positive impact on humans.
Arvind Singh The report shows that 6.6% were infected. Given the effacacy of the vaccine is 94% that is about right wouldn't you say? The vaccine is working at around the levels promised. It takes 10 days after the second injection to get to that level of protection. Exposure to the virus before then can result in infection. It's like buying armour one piece at a time and expecting to have full protection after the first piece. That's not how it works.
Dear Laura Bulgariu why should I not trust the vaccines which have already been approved and tested in phase III with ten thousands of test persons? In may country, Germany, two vaccines have now been approved (BioNTech/Pfizer and Moderna) and 1,324,901 people have already been vaccinated. This corresponds to 1,6% of the entire population in Germany.
Dear Laura Bulgariu currently the main problem in many countries around the world is that not enough vaccine doses are available. I this context please see this link entitled "New Pandemic Plight: Hospitals Are Running Out of Vaccines"
Dear Laura Bulgariu yes, everyone's hope to end the corona pandemic is based on successful vaccination of a hight percentage (ca. 70%) of the population. In my country, Germany, we have three priority groups. Right now only members of the first group (people over 80 years and health workers) are being vaccinated. Currently there is a shortage of vaccine doses throughout Europe (see e.g. this link: https://www.ft.com/content/59a014d0-aacc-43a5-b061-8ea4b25c3c00). With being under 70 years of age I belong to the third group. Thus I will not get vaccinated before ca. May 2021.
Dear Shridhar N B would you really prefer getting infected with the coronavirus? I think we can trust the currently available vaccines against COVID-19. Of course, they can have side effects, but apparently these are mostly mild and fairly rare. Please see this useful link entitled "COVID-19: Risks and side effects of vaccination"
every problem must has a solution: so Vaccine and care are the two basic prevention strategies that can control the COVID-19. if we don't not use Vaccine then we don't have any other alternate.