Make a clear statement with a two-way table and paragraphs to illustrate and discuss the components of statement.

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In the fight against COVID-19, a vaccine is a critical part of addressing the global health crisis by decreasing rates of infection, disease and death worldwide.

The Pfizer BioNTech COVID-19 vaccine is a messenger RNA (mRNA) vaccine that has both synthetic, or chemically produced, components and enzymatically produced components from naturally occurring substances such as proteins. The vaccine does not contain any live virus.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Risk from taking vaccine :-

1. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
2. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
3. adverse reactions in participants 16 years of age and older included pain at the injection site , fatigue , headache , muscle pain , chills , joint pain , fever , injection site swelling .
4. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Following precautions should be adopted while taking covid vaccination -

1. Wash your hands often with soap and water for at least 20 seconds.Use an alcohol-based hand sanitizer that contains at least 60% alcohol if soap and water are not available. Avoid touching your eyes, nose, and mouth with unwashed hands.
2. Avoid close contact with people who are sick.
3. Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
4. Maintain at least 1 meter (3 feet) distance between yourself and other people, particularly those who are coughing, sneezing and have a fever.

The Pfizer-BioNTech COVID-19 vaccine is 95% effective in preventing the COVID-19 virus with symptoms. This vaccine is for people age 16 and older. It requires two injections given 21 days apart. The second dose can be given up to six weeks after the first dose, if needed.

A single dose, however, was 74% effective against COVID-related hospitalization and 72% effective at preventing death.

There is euphoria following the pharmaceutical company Pfizer’s press release on November 9 that on a review of preliminary results, its vaccine candidate was found to be “more than 90% effective in preventing COVID-19” among trial participants.

The announcement was widely criticised for being misleading, while a number of other companies rushed to announce that their trial results were due shortly.

Over this clamour of claims and counterclaims, scientists have pointed out limitations in the way in which vaccine candidates are being tested, which requires a more sober appraisal. The urgent need for a vaccine against COVID-19 may lead to the use of vaccines of limited value and less than ideal information on their safety. The people must understand these constraints. They must also be assured that the vaccine will be rolled out with all the necessary precautions for follow-ups and the investigation of possible vaccine-related injuries.

For some months now, we have been following the race for a COVID-19 vaccine – the shot that will let us go back to living a normal life. This has been marked by dramatic flourishes.

One such was when the CEO of the Serum Institute of India, Adar Poonawalla, announced the manufacture of millions of doses of a number of vaccine candidates even before trials had started, so that if an effective vaccine was found, it would be available right away for distribution. Some months later, he tweeted asking the Indian government whether it was ready with Rs 80,000 crore so that all Indians could get the vaccine in the next year. All this, before the vaccine candidate has even been proven to work.

Such reports built up to a drumroll on November 9 when Pfizer issued a press release with the preliminary results of its vaccine candidate, developed along with BioNTech. The same day, WHO’s chief research officer tweeted: “The shot that rang across the world – Pfizer’s and BioNTech’s vaccine is the start of the end of the pandemic.” Shortly after Pfizer’s stocks rose by 15%. And interestingly, on the same day, its chief executive sold 62% of his stock at near-peak prices. The company also announced that it would have enough data to apply for emergency use authorisation in the US by the end of the month.

This was not surprising – only more evidence of the high financial stakes in the COVID-19 vaccine race. Indeed, a good amount of the reporting on COVID-19 vaccines consists of press releases with an eye on the market.

Now, we are given to understand that the vaccine is almost upon us, and the discussion has become focused on logistical issues, such as the need to store it at very low temperatures. And since there will be limited supplies initially, we are called upon to plan for who should get the vaccine on first.

While these questions are important, immunologists like Satyajit Rath have pointed out that we don’t yet have a vaccine. We only have a number of vaccine candidates. Dr Rath, a scientist at the National Institute of Immunology and the Indian Institute of Science Education and Research, Pune, was speaking during a webinar series on the science and ethics of COVID-19 vaccine research and access (this author moderated the second webinar). While there are 10 vaccine candidates in phase-3 clinical trials, none of them has so far released data to establish whether or not they work at all against the disease.

If and when a vaccine does become available, there are a number of issues we should address when preparing for a national COVID-19 immunisation programme.

First, the clinical trials to test the COVID-19 vaccine candidates are designed such that any vaccine that is proven to be effective will have limited value.

To sum up the process – in phase-3 vaccine trials, one group of participants is given the vaccine candidate, and the other group gets a saline solution, or placebo. Neither participant nor investigator knows who got which. Both groups are then monitored to see if they develop the disease that the vaccine candidate is designed to prevent. The number of cases of disease in each group will be compared to evaluate the efficacy of the vaccine. For the vaccine candidate to be judged efficacious, the control arm should have a greater proportion of cases. Researchers perform an efficacy analysis after a predetermined number of cases have been recorded. Final efficacy analyses in COVID-19 vaccine trials typically require 150-160 cases.

Peter Doshi, an assistant professor of pharmaceutical health services at the University of Maryland and associate editor at the BMJ

, has argued that the phase-3 COVID-19 vaccine trials are not designed to test for what we need to know – whether the vaccine candidate will prevent severe disease. He pointed out that the primary outcome for these vaccine trials is simply a laboratory-confirmed case of infection with SARS-CoV2, with at least one symptom – which could be as mild as a cough, fever or diarrhoea.

In Prof Doshi’s testimony to a US Food and Drug Administration (FDA) committee on the COVID-19 vaccine, he said that the vaccine candidates should be tested for how well they prevent severe illness leading to hospitalisation, ICU stay or death. The trials either don’t measure this or they are not set up to measure it well. In fact, the researchers stop the trials when they meet their target of 150-160 cases.

In order to evaluate efficacy against severe disease, these cases need to include sufficient numbers of severe disease, which is unlikely to happen, as severe disease is much less common than mild forms of the disease. The trials are also not designed to measure whether they reduce illness in those at greater risk, such as the elderly, or those with comorbidities. And they don’t collect the information needed to know if the vaccine could reduce transmission of the disease to bring the pandemic under control.

People should get two doses of the Pfizer and BioNTech vaccine within 21-28 days, the World Health Organization said on Tuesday, as many countries struggled to administer the jabs that can ward off the COVID-19 virus. Many are experiencing intensifying pressure on their health services due to surging coronavirus cases and the emergence of new variants that appear to spread more easily.

Governments are introducing new lockdown measures to halt the spread while facing massive demand for vaccines which are seen as the best way out of the global health crisis. But with jabs in limited supply as production ramps up, the WHO has been examining how they can be used most effectively.

"We deliberated and came out with the following recommendation: two doses of this (Pfizer) vaccine within 21-28 days," Alejandro Cravioto, chairman of WHO's Strategic Advisory Group of Experts on Immunization (SAGE), told an online news briefing. The panel said countries should have leeway to spread out shots over six weeks so that more people at higher risk of illness can get them.

"SAGE made a provision for countries in exceptional circumstances of (Pfizer) vaccine supply constraints to delay the administration of the second dose for a few weeks in order to maximise the number of individuals benefiting from a first dose," Cravioto said. He added: "I think we have to be a bit open to these types of decisions which countries have to make according to their own epidemiological situations."

More than 85 million people have been reported to be infected by the novel coronavirus globally and around 1.85 million have died, according to a Reuters tally.

SAGE executive Joachim Hombach said spacing out the two Pfizer inoculations could be acceptable for countries unable to implement the main recommendation. "The JCI, the recommending body of the UK, has given more flexibility up to 12 weeks in consideration of the specific circumstances that the country is currently facing," he said.

"We...totally acknowledge that countries may see needs to be even more flexible in terms of administration of the second dose. But it is important to note that there is very little...empirical data from the trials that underpin this type of recommendation," he added. Given the limited supply of vaccines at present, Cravioto said SAGE did not recommend the Pfizer jab for international travellers as a priority unless they were in a very high-risk group, such as the elderly and those with pre-existing ailments.

Kate O'Brien, a WHO immunization expert, said there was a robust discussion at SAGE about the trade-off between adhering strictly to standard dosing in clinical trials and allowing for a broader use of vaccine as first doses, thus risking delay in getting the second dose out to some people.

Alluding to delays in rolling out inoculations, she said: "Nobody expected this to be easy and we are starting to see where the road bumps are and where we need to make adjustments." Tedros Adhanom Ghebreyesus, WHO director-general, said he was "very disappointed" that China had not authorised entry of an international mission to examine the origins of the global coronavirus pandemic.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

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