Home Business How the Pfizer vaccine – just provisionally approved in SA – was...

How the Pfizer vaccine – just provisionally approved in SA – was designed in a few hours

38
0
How the Pfizer, just provisionally approved in SA –was designed in a hours

South Africa’s medicine authority has provided Section 21 approval for the Pfizer and BioNTech’s coronavirus vaccine, allowing it to be rolled out.

The vaccine was designed by BioNTech co-founder Ugur Sahin in one day: January 25 in 2020.

In fact, according to The Wall Street Journal’s podcast, Sahin designed the vaccine in just a few hours.

 

On Tuesday, the South African Health Products Regulatory Authority (Sahpra) approved the Section 21 application for the Pfizer/BioNTech Covid-19 vaccine.

That means the sought-after vaccine has been approved for distribution, though doing so is subject to monitoring the vaccine’s efficacy and safety.

Remarkably, BioNTech co-founder Ugur Sahin designed the Pfizer and BioNTech vaccine in just a few hours in mid-January 2020, according to The Journal, a podcast from Gimlet and The Wall Street Journal.

A BioNTech spokesperson confirmed to SA TIMES that Sahin – who founded the company with his wife, Özlem Türeci – made a “rough design over one weekend.”

Moderna’s vaccine also took just two days to design, as SA TIMES NEWS  previously reported. The reason both candidates could be designed so quickly comes down to the technology they rely on: messenger RNA, or mRNA.

How mRNA vaccines train the body to fight the coronavirus

 

mRNA vaccines

How mRNA vaccines are developed.

 

Messenger RNA is genetic material that tells cells how to make proteins. Pfizer’s coronavirus vaccine candidate works by injecting a small piece of coronavirus mRNA into the body. That RNA codes for the virus’ spike protein, which is what helps it attach to and invade cells. That’s also what antibodies target and neutralise.

So the mRNA vaccine spurs the body to produce the spike protein internally in order to trigger that same immune response.

 

Moderna’s vaccine works in the same way.

 

Utilizing mRNA vaccine technology meant BioNTech and Moderna only needed the coronavirus’ genetic sequence to design a vaccine. That’s why they could move forward so quickly.

How BioNTech and Pfizer joined forces 

On January 24, Sahin read a paper in The Lancet that described Chinese family members who travelled to Wuhan then contracted Covid-19.

“What was most concerning is that one of the family members had the virus and was

virus-positive but did not have symptoms,” Sahin told The Journal. This meant that the virus could be transmitted by asymptomatic carriers – and had probably already spread out of China.

“The math behind it just showed me it will happen, it’s just a matter of a few weeks,” Sahin said.

He decided to shift BioNTech’s focus toward a coronavirus vaccine. The following week, Sahin told the company that operations going forward would be devoted mostly to developing and testing the vaccine.

Using the coronavirus’ genetic sequence, which Chinese researchers published on January 11, Sahin designed 10 different candidates on his computer that weekend. One was the candidate later selected for larger trials.

Sahin designed that winning candidate in just a few hours, according to The Journal.

But BioNTech, with a pre-pandemic workforce of 1,000, didn’t have the capacity to manufacture the hundreds of thousands of doses needed for large-scale trials – let alone the hundreds of millions it would need if the vaccine worked.

So in February 2020, Sahin called Pfizer’s head of vaccine research, Kathrin Jansen; BioNTech had worked with Pfizer since 2018 on a flu vaccine.

“This is a disaster, and it’s getting worse,” Dr. Jansen told Dr. Sahin, according to The Wall Street Journal. “Happy to work with you.”

The two companies announced their partnership in mid-March last year.

 

Kathrin Jansen, Pfizer’s head of vaccine research and development.

Pfizer

 

Pfizer would manage the logistics, including manufacturing the vaccine in large batches

and organising the Phase 3 trial, which wound up involving 43,500 volunteers.

BioNTech, meanwhile, handled the vaccine’s design.

Pfizer and BioNTech announced that their vaccine was more than 90% effective last year.

When Pfizer CEO Albert Bourla told told senior company officials of the findings, people

jumped up from their chairs, The Wall Street Journal reported.

The full results of the Phase 3 trial were even stronger: The findings, published in the New

England Journal of Medicine on Thursday, suggest that the vaccine doesn’t trigger severe

side effects in most people and is 95% effective at preventing Covid-19.

Anthony Fauci, America’s leading infectious-disease expert, called the results “just extraordinary” and said they would

“have a major impact on everything that we do with regard to Covid.”

The speed at which BioNTech and Pizer developed the vaccine does not mean they

sacrificed thoroughness, according to Albert Rizzo, chief medical officer for the American Lung Association.

“We’re not skipping steps – we actually have better technology,” Rizzo previously told SA TIMES NEWS .

“Why did it take two weeks to cross the Atlantic back in the 1800s? Well, we had to go on

a boat. Whereas now, you can get across the ocean in several hours.”

The pros and cons of mRNA vaccines 

For decades, vaccines contained a dead or weakened version of a virus itself.

Then early advances in genetics allowed vaccines to use proteins made by the virus instead.

That method was first used in the 1980s to develop a vaccine for hepatitis B.

Companies like Novavax are relying on the same protein-based model to create their coronavirus vaccine candidates.

But BioNTech was founded on the idea that mRNA could be used to develop cancer

vaccines, hence its mRNA-based approach to the coronavirus.

One of the company’s senior vice presidents, biochemist Katalin Karikó, first discovered

how to configure mRNA to be used in vaccines.

Since RNA vaccines aren’t cultivated using cells, they’re quicker to produce.

The drawbacks of Pfizer and BioNTech’s vaccine, however, are that people must get two

injections three weeks apart, and it needs to be shipped at about -70 degrees Celsius.

That requires dry ice and special freezers.

Several studies are ongoing to determine how long the vaccine will protect people from

Covid-19, whether it can prevent transmission and asymptomatic infection, and to what

extent it will protect against new variants of the coronavirus.