The FDA says Pfizer’s Covid vaccine is safe and effective. But trial participants warn of intense symptoms after second shot

CNBC:

  • The FDA said data from Pfizer’s Covid vaccine trials show that side effects are common, though there are “no specific safety concerns identified that would preclude issuance of an” emergency use authorization.
  • Trial participants in the Moderna and Pfizer studies told CNBC they developed more significant symptoms following the second dose.

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 indicated that it could greenlight the country’s first Covid-19 inoculation within days. 

If Pfizer’s shot is granted an emergency use authorization, or EUA, the immunizations — which are administered in two doses about three weeks apart — could start as soon as next week.

Many people are now wondering whether this will be just like getting the flu vaccine. 

The short answer is: No, not really.

One Pfizer trial participant told CNBC that after the second shot, he woke up with chills, shaking so hard he cracked a tooth. “It hurt to even just lay in my bed sheet,” he said. 

Others experienced headaches and fatigue.

The FDA said that while side effects of the Pfizer vaccine are common, there are “no specific safety concerns identified that would preclude issuance of an EUA.”

Be prepared for the second shot

The Pfizer vaccine is one of four U.S.-backed candidates in phase three trials. Next up is one from U.S. biotech firm Moderna, which has also submitted its EUA application.

Both companies have said that taking their vaccines could result in side effects similar to mild Covid symptoms. Think muscle pain, chills and a headache.

When trial participant Yasir Batalvi first read Moderna’s 22-page consent form warning of side effects ranging from nothing at all to death, he felt pretty worried, he told CNBC.

“You have to keep in mind, I joined the trial when we didn’t know it was going to be a safe vaccine,” said Batalvi, a recent college graduate living in Boston.  

The 24-year-old said that when he got the first injection in mid-October, it felt just like a flu shot. “I experienced stiffness and pain in my left arm where I had gotten the shot, but it was mild,” he explained. “By that evening, I didn’t want to move my arm above my shoulder, but it was localized, and it disappeared by the next day.”

The second dose was a different story.

“After the injection, I had the same side effects as the first: localized pain and stiffness, but it was a little bit worse. My arm got sore faster, and by the time I got home, I started feeling fatigued and like anyone would feel if they were coming down with the flu,” said Batalvi.

More significant symptoms presented that evening. “I developed a low-grade fever and had chills,” he said. “That evening was rough.”

Read more at CNBC

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