Forget 2020. We are stuck with the virus for the rest of the year and a good portion of 2021, despite strong movement on the vaccine development side.
We are looking at the summer of 2021 at the earliest when we can finally go back to some normalcy. But it’s a guess.
Here’s what we know
A CNN interview with BioNTECH
In an exclusive interview with CNN’s Frederik Pleitgen, BioNTech CEO Uğur Şahin said that the company, which has been working on a Covid-19 vaccine with Pfizer, will file paperwork for the emergency use of its vaccine with the US Food and Drug Administration (FDA) this Friday, expecting the approval process to be completed and distribution to begin before the end of the year.
Watch the CNN video interview here.
“I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal winter 2021, a normal summer and winter 2021.”
Concerns have been raised that it would be difficult to distribute the BioNTech/Pfizer vaccine because it needs to be stored at around -75 degrees Celsius. But Şahin tells CNN that this is a temporary issue that will be resolved.
Pfizer had announced that a final analysis of the Phase 3 trial of its coronavirus vaccine showed it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns.
“The risk of getting Covid-19 if you are vaccinated is twentyfold less as compared to having no vaccine,” Şahin said.
“Our goal is to supply several hundred million of doses in the first four to five months of 2021.”
Where are we in the UAE?
A United Arab Emirates company is nearing the end of Phase III clinical trials of a Chinese COVID-19 vaccine and hopes to manufacture it next year.
The trial, which began in mid-July, is a partnership between Sinopharm’s China National Biotec Group (CNBG) and Abu Dhabi-based artificial intelligence and cloud computing company Group 42 (G42).
It has been administered to more than 31,000 people in the UAE, Egypt, Bahrain, and Jordan, G42 Healthcare CEO Ashish Koshy said in October, adding that results analysis and publication will happen in around two months.
The target is to produce between 75 and 100 million doses next year in the UAE.
On November 3, Sheikh Mohammed bin Rashid Al Maktoum became the latest Emirati official to get the Sinopharm vaccine.
Phases of vaccines
Scientists are racing to produce a safe and effective coronavirus vaccine by next year. Researchers are testing 54 vaccines in clinical trials on humans, and at least 87 preclinical vaccines are under active investigation in animals.
Work began in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March, and now 12 have reached the final stages of testing.
The status of the 2 top vaccines that have reached trials in humans is below.
While these vaccines may potentially prevent infection, they cannot cure the disease.
1. Preclinical testing:
Scientists test a new vaccine on cells and then give it to animals such as mice or monkeys to see if it produces an immune response. There are 87 confirmed preclinical vaccines in active development.
2. Phase 1 safety trials:
Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
3. Phase 2 expanded trials:
Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them.
4. Phase 3 efficacy trials:
Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus. In addition, Phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.
In June, the FDA advised vaccine makers that they would want to see evidence that vaccines can protect at least 50% of those who receive them.
China and Russia have approved vaccines without waiting for the results of Phase 3 trials. Experts say the rushed process has serious risks.
During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.
Top 2 promising vaccines in Phase 3
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 coronavirus. 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 provided nearly $1 billion in support of Moderna.
On Nov. 16, Moderna announced that a preliminary analysis of the trial indicated that the vaccine was 94.5% effective.
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.
On Nov. 9, New York-based Pfizer and the German company BioNTech made history by presenting preliminary data indicating that their coronavirus vaccine was over 90% effective.
In May, Pfizer and BioNTech launched a Phase 1/2 trial on two versions of an mRNA vaccine. They found that both versions caused volunteers to produce antibodies against SARS-CoV-2, as well as immune cells called T cells that respond to the virus.
On July 27, the companies announced the launch of a Phase 2/3 trial with 30,000 volunteers and on September 12 they expanded their US trials to 43,000 participants.