Coronavirus - How Different Companies Developed a Covid-19 Vaccine
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Pfizer and Moderna are likely to be the first companies to see their respective vaccines authorized in the United States, possibly before the end of 2020. Though their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different. Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market. Yet when the COVID-19 pandemic began, both companies bet big on a brand-new vaccine technology called mRNA. Moderna had been working on the technology for years, while Pfizer partnered with a smaller German biotechnology company BioNTech for its mRNA research.

 

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After rapidly testing their vaccines in early-stage studies, Pfizer and Moderna launched their massive Phase 3 trials, which is the last step before authorization, on July 27, 2020. And the companies have been neck in neck since then, with Moderna ultimately emerging with key data milestones about a week behind Pfizer because of subtle differences in its trial design and vaccine dosing.

 

 

Pfizer declined an initial research investment from the US government’s Operation Warp Speed, a multibillion-dollar program to accelerate the development and distribution of COVID-19 vaccines. But Moderna has been partnered with the government from the start, enjoying a longstanding research collaboration with the National Institutes of Health, accepting $955 million in funding from the Biomedical Advanced Research and Development Authority (BARDA). Both companies have accepted Operation Warp Speed funding in exchange for a promise that the first 100 million doses of their respective vaccines will be delivered to the U.S. government.  And when it comes to their vaccines, both Pfizer and Moderna’s are quite similar.

 

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Days Left by Country Until Herd Immunity to Covid-19  is Reached Through Vaccinations Around the World 

 

 

 

“They’re using something called an mRNA technology, which is relatively new in vaccine development,” said Azra Behlim, senior director of pharmacy sourcing and program services at Vizient.

 

 

Compared to some other vaccine technologies, mRNA is a more delicate product, Behlim told ABC News, meaning it needs to be kept frozen for long term storage. Moderna’s vaccine can be kept in normal freezer temperatures, like the freezer you have at home. Pfizer’s vaccine, meanwhile, must be kept in a specialized ultra-cold freezer at -94 degrees Fahrenheit. Once thawed, the Moderna vaccine can be kept in a normal refrigerator for a month, while Pfizer’s can only be kept in a typical fridge for five days.

 

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“Some of those cold chain storage issues that the Pfizer vaccine brought up ... could be alleviated with [Moderna's] vaccine,” said Dr. Colleen Kelley, associate professor of medicine at Emory University School of Medicine and principal investigator for the Moderna study at the Ponce de Leon Center. “This is good news for places that may not have access to that ultra-cold storage,” said Kelley. That could include more rural parts of America.  Operation Warp Speed Vaccine Development Lead Dr. Matt Hepburn said, "the fridge-for-a-month distribution point we made really enables for a much more distributed model to get the vaccine out there, potentially for example in very rural areas."

 

 

But with limited supplies of each vaccine available at first, enough to vaccinate only 20 million Americans by the end of the year, experts agree the U.S. needs multiple vaccines to fight the pandemic. That includes not only Pfizer and Moderna's vaccine but also even more that are further behind in development.   Two other companies that received funding for clinical research from Operation Warp Speed -- AstraZeneca and Johnson & Johnson -- had brief setbacks when their late-stage trials were paused over safety concerns. But those trials are now back up and running and may have data available in the coming weeks and months. “We will not see the other side of this pandemic without an effective vaccine, and multiple effective vaccines,” Kelley said.

 

J and J vaccine FDA approved

FDA Advisory Panel Endorses Third Covid-19 Vaccine - Johnson & Johnson - for Emergency Use  - 2 26 2021

 

Johnson & Johnson’s one-dose COVID-19 vaccine appeared safe and effective in trials, the U.S. Food and Drug Administration said, paving the way for its approval for emergency use  on February 26, 2021.  The vaccine was 66% effective at preventing moderate to severe COVID-19 in a 44,000 person global trial, the FDA said in documents ahead of a Friday meeting of independent experts who will advise the agency on emergency authorization. New data provided by J&J to the FDA showed the vaccine was 64% effective at stopping moderate to severe cases of COVID-19 after 28 days in thousands of trial participants in South Africa where a worrying new variant has swept across the country.

 

Johnson Johnsons COVID 19 vaccine

 

Overall, the vaccine was 100% effective at stopping hospitalization 28 days after vaccination, compared with 85% at 14 days, and there were no COVID-19 deaths among those who received the shot rather than a placebo. J&J also said the data suggested its vaccine cut down on asymptomatic infections, which experts said was another sign COVID-19 vaccines may indeed stop transmission of the disease.

 

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“Most encouraging to me were the data in South Africa,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA advisory committee that will make its recommendation on Friday. “That you could still get protection against medically attended illnesses - meaning hospitalization, ICU admission and deaths from that vaccine against the South African strain, I thought that was really encouraging.”

 

 

The vaccine is administered in a single dose and can be stored in normal fridges, in contrast to the Pfizer and Moderna shots which need two doses and must be kept in freezers.  The J&J vaccine is also considered essential in the global vaccination effort due to its routine storage requirements and is already being rolled out to 500,000 healthcare workers in South Africa. J&J said in documents submitted to the FDA that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate. While fighting asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.  “The data is consistent with the fact that these coronavirus vaccines, including the J&J vaccine, do have an impact which is significant on asymptomatic spread,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

 

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However, he said some public health authorities may ask to see more robust data before being persuaded.  The effectiveness of the one-dose vaccine varied over time. In Brazil, where a similar variant to the one in South Africa is circulating, the vaccine was 66% after 14 days, rising to 68% at 28 days. In the United States, the effectiveness fell from 74% at 14 days to 72% two weeks later. Overall, only two vaccine recipients developed COVID-19 severe enough to need medical intervention after 14 days and that dropped to zero after 28 days. J&J has said it sees rising immunity from its vaccine until at least 28 days after injection. The drugmaker has said it expects sustained - or even improved - protection over time.

 

Covid CUp Bottles vaccines

 

SIDE EFFECTS:  Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization. The FDA said the most common reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine. The regulator said one case of pericarditis, a heart disease, may have been caused by the vaccine. It said cases of a rare disorder, Guillain-Barre Syndrome, were unlikely to be related to the shot though data was insufficient to determine whether the vaccine had caused these side effects.