When we will get Vaccinated?

 

Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to supply a secure and effective corona-virus vaccine by next year. Researchers are testing 55 vaccines in clinical trials on humans, and a minimum of 87 preclinical vaccines are under active investigation in animals.

PRECLINICAL TESTING: Scientists test a replacement vaccine on cells then provides it to animals like mice or monkeys to ascertain if it produces an immune reaction . we've confirmed 87 preclinical vaccines in active development.

PHASE 1 SAFETY TRIALS: Scientists give the vaccine to a little number of individuals to check safety and dosage also on confirm that it stimulates the system .

PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to many people split into groups, like children and therefore the elderly, to ascertain if the vaccine acts differently in them. These trials further test the vaccine’s safety and skill to stimulate the system .

PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of individuals and wait to ascertain what percentage become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the corona-virus. In June, the F.D.A. advised vaccine makers that they might want to ascertain evidence that vaccines can protect a minimum of 50 percent of these who receive it. additionally , Phase 3 trials are large enough to reveal evidence of relatively rare side effects which may be missed in earlier studies.

EARLY OR LIMITED APPROVAL: China and Russia have approved vaccines without expecting the results of Phase 3 trials. Experts say the rushed process has serious risks.

APPROVAL: Regulators in each country review the trial results and choose whether to approve the vaccine or not. During an epidemic , a vaccine may receive emergency use authorization before getting formal approval. Once a vaccine is licensed, researchers still monitor people that receive it to form sure it’s safe and effective.

COMBINED PHASES: a method to accelerate vaccine development is to mix phases. Some coronavirus vaccines are now in Phase 1/2 trials, for instance , during which they're tested for the primary time on many people. (Note that our tracker counts a combined Phase 1/2 trial as both Phase 1 and Phase 2.)

Moderna develops vaccines based on messenger RNA (mRNA) to produce viral proteins in the body. They have yet to bring one to the market. In January, they began developing a vaccine for the corona-virus. The vaccine contains genetic instructions for building a coronavirus protein, known as spike. When injected into cells, the vaccine causes them to make spike proteins, which then get released into the body and provoke a response from the immune system.

The United States government bankrolled Moderna’s efforts, providing nearly $1 billion in support. In partnership with National Institutes of Health, they found that the vaccine protects monkeys from the coronavirus. In March, the scientists were the first to put a Covid-19 vaccine into human trials. After those studies yielded promising results, Phase 3 testing on 30,000 volunteers began on July 27.

On Nov. 16, Moderna announced that a preliminary analysis of the trial indicated that the vaccine was 94.5 percent effective. Out of 95 participants who got Covid-19, 90 had the placebo and only 5 had the vaccine. The results came just a week after Pfizer made a similar announcement about their own vaccine, which is also based on an mRNA molecule encoding the spike protein. Another promising result from Moderna’s trial was the finding that the vaccine appears to protect people from severe disease. Of the 11 volunteers who developed severe disease, none were vaccinated. The trial will continue to gather more results; Moderna says it plans to submit an application for an emergency use authorization in the next few weeks.

On the business side, Moderna lost a patent dispute in July over some of their vaccine technology. The following month, the company stated that it could not be certain it was the first to make the inventions claimed in their patents, including its coronavirus vaccine. Meanwhile, the company has entered deals with several countries to supply the vaccine if it’s approved. On Aug. 11, the United States government awarded the company an additional $1.5 billion in exchange for 100 million doses if the vaccine proves safe and effective. Moderna has made similar deals with Canada, Japan, and Qatar.

 

Pfizer, which developed the vaccine with its partner BioNTech, said the companies planned to apply to the Food and Drug Administration for emergency authorization “within days,” raising hopes that a working vaccine could soon become a reality.

The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects — the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe.

The data showed that the vaccine prevented mild and severe forms of Covid-19, the company said. And it was 94 percent effective in older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines. If the F.D.A. authorizes the two-dose vaccine, Pfizer has said that it could have up to 50 million doses available by the end of the year, and up to 1.3 billion by the end of next year.

 However, only about half of its supply will go to the United States this year, or enough for about 12.5 million people — a sliver of the American population of 330 million. Americans will receive the vaccine for free, under a $1.95 billion deal the federal government reached with Pfizer for 100 million doses.

 The companies said that out of 170 cases of Covid-19, 162 were in the placebo group, and eight were in the vaccine group. Out of 10 cases of severe Covid-19, nine had received a placebo.

Pfizer and BioNTech said that the vaccine’s efficacy was consistent across age, race and ethnicity. The most common serious adverse event was fatigue, with 3.7 percent of volunteers reporting tiredness after they took the second dose. Two percent of volunteers reported a headache after the second dose. Older adults reported fewer and milder side effects, the companies said.

“It’s pretty amazing,” said Akiko Iwasaki, an immunologist at Yale University. She said the results in people over 65 were the most promising. “We know from the influenza vaccine that it’s very difficult to achieve protection in this age group with vaccines,” she said, so 94 percent efficacy in that group “is really remarkable.”

Federal health officials have said the first doses of the vaccines will most likely go to groups like health care workers who are at high risk for exposure, as well as to people who are most vulnerable to the disease, such as older people.

 Note: But one of the biggest problems in these two vaccines is that they can be stored only in deep freeze. Whose temperature is minus 70 degrees Celsius. 

Pfizer's covid-19 vaccine "distribution will be a logistical nightmare." Cold chain logistics will be big challenge in vaccinating 135 crore Indians. We have certain smaller cold rooms that can store a million dose at 40 degrees also but not in a huge volume so probably in a month 2 million dose can be handled at 30 to 40 degrees according to Indian government.

Ramping up cold storage facilities critical as India preparations for covid-19 vaccine expert airline and airports get ready for operation covid vaccine.

Side effects of vaccine

• Moderna reported more grade 3 side effects. There was fatigue in 9.7 % of recipients, muscle pain in 8.9% joint pain in 5.2 % headache in 4.5 % pain in 4.1% and redness at the injection on-site in 2%.

• Pfizer reported 3.8 % of the recipient felt fatigue and 2% experienced headache, based on preliminary data from its phase 3 trials.

• No other major side effects until now, will continue monitoring said doctors. Doctors also said that the side effects of the vaccine can be seen even in 6 months.

Who will get the vaccine first?

• Covid-19- 30000000 frontline workers to be vaccinated 1st says health ministry.

• According to Modi government has set aside Rs 50,000 crore to give covid vaccine to entire country.

• On 11 August 2020 Russia approves first coronavirus vaccine 'Putin' says his daughter received dose.

• The announcement of the 'Sputnik V' vaccine for covid-19 was made by Russia. However, the vaccine is yet to complete final result.

When everything will be back to the normal?

• Drug makers push forward on large scale production of coronavirus vaccine which is called at risk manufacturing we don't know if our vaccine will work or not but if done we will get the license for further manufacturing.

• Pfizer and Moderna covid vaccine could be ready for US use in weeks.

• India to get covid-19 vaccine by med 2021 says BIOCON's Kiran Mazumdar say. Common people have to wait till 2022 to to get covid-19 vaccine AIIMS director Dr Randeep Guleria said.