All About Pfizer Vaccine | UPSC

All About Pfizer Vaccine | UPSC

      HEADLINES:

COVID-19 vaccine could be 90% effective, claims Pfizer

      WHY IN NEWS:

It may apply for emergency use nod in the U.S.

SYLLABUS COVERED: GS 3:Health:Diseases

      LEARNING: 

For PRELIMS you should make a note on mRNA technology today itself . Try to decode its principle and how the vaccine works inside the body .

For MAINS go with way forward where we have mention few hurdles in distribution of vaccine . Let us dive in !

      ISSUE: 

Pharma major Pfizer claimed its coronavirus vaccine suggests the shots may be a robust 90% effective at preventing COVID-19.

PFIZER VACCINE

  • The company is on track to apply for emergency-use approval from the U.S. Food and Drug Administration.
  • The COVID-19 shot receiving emergency authorisation are closer to reality.
  • The findings are critical as the vaccine is headed for a review by the US Food and Drug Administration (FDA).

COVID-19 has killed more than 1.2 million people worldwide, including almost a quarter-million in the U.S. alone.

  • Pharmaceutical companies and various countries are in a global race to develop a vaccine against the virus.

DEVELOPERS

 The Covid-19 vaccine is developed by U.S. drugmaker Pfizer and German biotech firm BioNTech.

  • US drug-maker Pfizer has released preliminary data from late-stage human trials.

All About Pfizer Vaccine | UPSC

All About Pfizer Vaccine | UPSC

INTERIM ANALYSIS

  • This interim analysis, from an independent data monitoring board, looked at 94 infections recorded.
  • So far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.

The company’s first interim efficacy analysis signals an effectiveness against Covid-19.

  • The vaccine has been found more than 90% effective.

WHAT TYPE OF VACCINE HAVE PFIZER AND BIONTECH DEVELOPED?

  • This is a vaccine that was developed using mRNA technology .

mRNA
It makes use of the messenger RNA molecules that tell cells what proteins to build.

  • The mRNA, in this case, is coded to tell the cells to recreate the spike protein of the novel coronavirus.
  • Once the mRNA is injected into the body, the cells will use its instructions.

It will create copies of the spike protein, which is in return expected to prompt the immune cells to create antibodies to fight it.

  • Unlike several other vaccine candidates, mRNA vaccines are synthetically developed .
  • They don’t need the virus to be cultivated and replicated.
  • mRNA just the code for the most crucial part that the body’s immune system is to target.

Another advantage is that they can be manufactured at a large scale in large vats called bioreactors.

  • After getting the code for the virus, it is possible to develop the vaccine within weeks for pre-clinical testing.
  • Compared with other vaccines which take months.

WHAT DO THE EARLY RESULTS SAY?

According to the findings, the vaccine was “more than” 90% effective in preventing Covid-19 among participants who had received a second dose.
 

  • The trial were conducted as opposed to those participants who had only received a placebo.

The firm also said that analysis of the late-stage trial data showed that there were no serious safety concerns.

  • Considering that the US FDA as well as several international regulators have suggested that a vaccine has to be able to protect at least 50% of those receiving it.
  • Thus the findings in Pfizer and BioNTech’s case seem promising.
  • The results demonstrate that our mRNA-based vaccine can help prevent Covid-19 in the majority of people.
  • This means we are one step closer to an end of this global pandemic.

The phase 3 trials of this vaccine candidate — BNT162b2 — began on July 27 .

  • So far in phase 3  43,538 participants have enrolled, 38,955 of whom had received a second dose as of November 8.

VACCINE APPROVAL IN U.S.

  • Not necessarily the vaccine will get an approval.
  • The interim results released today were of only 94 out of nearly 40,000 volunteers who were injected with the vaccine candidate.

It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone.

  • More data on safety is also needed . Pfizer and BioNTech are currently accumulating this additional safety data.
  • It is estimated that it will take until the third week of November for the company to accumulate safety data .
  • Another mRNA candidate, by US firm Moderna has also been a frontrunner in the race of vaccine
  • The firm also expects the required readout from late-stage human trials later this month.

WILL INDIA GET ACCESS TO THIS VACCINE?

  • So far, no.The firms have so far inked deals for hundreds of millions of doses with countries like the US, UK, Japan and the European Union region.
  • The firm is expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
  • Indian government had held an “initial meeting” with Pfizer’s Indian subsidiary in late August after early phase 1 data of the vaccine.
  • There has been no major movement on that front since.

As per India’s regulatory requirements, a vaccine would have to undergo local trials in the country before it can receive an approval for a launch.
 

  • India is majorly focused on five other Covid-19 vaccine candidates, being tested by Serum Institute of India, Bharat Biotech, Zydus Cadila.

      IASbhai WINDUP: 

MAJOR ROADBLOCKS

  • The vaccine may run into logistical issues on account of cold storage.
  • The vacccine candidate reportedly needs to be stored at temperatures below -90°F.

This would require an ultra-cold storage system, as storing it at refrigerated temperatures for more than two days may render it ineffective.

  • This means major constraints in storage and distribution in countries like India.
  • India is still mapping and scaling up its cold storage footprint to store even vaccines at refrigerated temperatures.
  • Even countries with more robust cold chain systems may have to invest more to adhere to these stricter conditions.
SUGGESTED READING : HOW TO DISTRIBUTE COVID-19 VACCINE? 
     SOURCES:  THE  IE  | All About Pfizer Vaccine | UPSC

 

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