As it’s in Pfizer, Moderna trials
The Pfizer BioNTech coronavirus vaccine is both safe and effective, according to the U.S. Food and Drug Administration. In a report released Tuesday morning, the FDA said it could give the country’s first Covid-19 vaccination the green light within days.
If Pfizer’s shot is given an Emergency Clearance (EUA), the vaccinations – which are given in two doses about three weeks apart – could start as early as next week.
Many people are now wondering if this will just be like getting the flu vaccine.
The short answer is, no, not really.
A Pfizer participant told CNBC that after the second shot he woke up with chills and shaking so badly that he cracked a tooth. “It hurt just lying in my sheets,” he said.
Others had headaches and tiredness.
The FDA said that while side effects from the Pfizer vaccine are common, “no specific safety concerns have been identified that would preclude the issuance of an EEA”.
Be prepared for the second shot
The Pfizer vaccine is one of four US-supported candidates in Phase 3 trials. Next comes one from the US biotech company Moderna, which has also submitted its EUA application.
Both companies have stated that taking their vaccines can lead to side effects similar to mild Covid symptoms. Think of muscle aches, chills, and headaches.
When study participant Yasir Batalvi first read Moderna’s 22-page consent form for side effects ranging from nothing to death, he was quite concerned, he told CNBC.
“You have to remember, I joined the study when we didn’t know it was a safe vaccine,” said Batalvi, a recent Boston graduate student.
The 24-year-old said when he got the first injection in mid-October it felt like a flu shot. “I had stiffness and pain in my left arm where I got the shot, but it was mild,” he explained. “I didn’t want to move my arm over my shoulder until that evening, but it was located and disappeared the next day.”
The second dose was a different story.
“After the injection I had the same side effects as the first time: localized pain and stiffness, but it was a bit worse. My arm got sore quicker and when I got home I felt tired and like everyone would feel when they got the flu, ”said Batalvi.
That evening the symptoms were more significant. “I developed a low fever and had chills,” he said. “That evening was tough.”
I developed a low fever and had chills. That evening was tough.
Moderna test participant
After a restless night, he called the study doctors who assured him it was a normal reaction and nothing to worry about. That afternoon, said Batalvi, he felt like him again.
Moderna stopped testing the highest dose of its vaccine during the study due to numerous serious side effects reported.
In terms of long-term effects, Batalvi doesn’t think much about it. “I’m not too worried,” he said. “We know from vaccination trials that adverse events mostly occur in the first few months.”
How an mRNA vaccine works
Top runners Pfizer and Moderna built their candidates with a new technology that has never been licensed in the US
Messenger RNA vaccines, or mRNA for short, are not like regular flu vaccines. Typically, a vaccine brings a weakened or inactivated virus into our body to trigger an immune response that then produces antibodies. These antibodies ultimately protect us from infection if we ever encounter reality.
An mRNA vaccine, on the other hand, is essentially just a piece of genetic code that contains instructions for our bodies. The mRNA tells our cells to make a protein – the same protein that spikes the top of the actual coronavirus. That triggers the immune response in these types of vaccines.
Although some study participants reported Covid-like symptoms, it is impossible to pull the coronavirus out of the vaccine because the mRNA vaccines made by Pfizer and Moderna do not use the live virus.
Dr. Hana El Sahly, who oversees a clinical trial for Moderna’s vaccine candidates, said a key benefit of mRNA technology is how quickly it can be made. “The appeal is the speed with which it can be made once we know the sequence of the virus,” said El Sahly.
With the traditional flu vaccine, the virus must first be grown in an egg, then deactivated, and finally filled into vaccine bottles using mRNA or recombinant DNA technology, El Sahly explained.
Faster time to manufacture the Covid vaccine is critical as traders seek to expedite distribution to the U.S. population.
Pay for the vaccine
Also, the key to widespread vaccination is making sure that governments around the world have enough money to buy the vaccines.
Moderna said in August that it charges between $ 32 and $ 37 per dose for its vaccine and would potentially offer a discount if bought in bulk. Pfizer, on the other hand, is cheaper. It’s supposedly $ 20 a dose.
The US received 100 million doses of the Pfizer vaccine, which is enough to vaccinate 50 million people.
According to experts, in order to achieve herd immunity, around 70% of the population must be vaccinated or have natural antibodies. That’s roughly 462 million doses for herd immunity and an estimated 660 million doses for everyone in the country.
Pfizer board member Dr. Scott Gottlieb told CNBC on Tuesday that President Donald Trump turned down the company’s offer to buy additional cans.
A debate about unblinding the control group
Both Pfizer and Moderna are conducting double-blind studies, which means half of the participants will be given a placebo and half will be given the actual vaccine. Because the experiments have not yet been completed also means that patients do not know which group they are in.
A debate is raging among experts about whether the control group should receive the vaccine.
The FDA isn’t particularly interested in the idea of dosing the placebo group, while some scientists feel it should be prioritized higher in thanks for their service.
However, this type of interruption of the experimental log would compromise the integrity of the experiment. Therefore, participants like Batalvi remain in the dark for the time being as to whether they are actually protected from the virus. A person can still show symptoms like Batalvi did, even if they are in the control group. It’s the “placebo effect”.
In any case, Batalvi said he was glad he had the opportunity to join efforts to protect the world from the pandemic.