What does it mean for vaccinators when Pfizer and BioNTech release promising but only preliminary test results for a vaccine they have developed?
Pfizer Inc. (PFE) and BioNTech have released promising, but only preliminary, test results for the new coronary vaccine they have developed. Here’s what we know and don’t know yet, and what it means for vaccinators.
When will the Pfizer vaccine be licensed?
Weeks at the earliest, as researchers and regulators still need to ensure the safety of the vaccine. The U.S. Food and Drug Administration (FDA) says it wants to see two-month safety results from at least half of the subjects in a large, final clinical trial before considering approval of the new human clay vaccine. the FDA says any side effects of the vaccine will be identified in the process, such as neurological or Heart symptoms, which are not evident in the short term after vaccination. So far, Pfizer says, no serious safety issues have been identified. Pfizer expects to receive two months of safety data later this month, after which it can ask the FDA to approve the vaccine. It’s unclear how long it will take for the FDA to make a decision.
When will people be able to get this vaccine?
Production of the vaccine has already started and supply could begin by the end of the year, but initially the supply will be limited. Pfizer estimates that up to 50 million doses of the vaccine will be produced globally in 2020, and because the vaccine is administered in two doses, these will be enough for 25 million people, and up to 1.3 billion doses will be produced in 2021. That means only the highest-risk groups are likely to receive the vaccine this year, such as frontline health care workers. And much more than that would be needed to cover the entire U.S. and world population. Full vaccination coverage also depends on other vaccines in the pipeline. The makers of these vaccines expect that if their vaccines are successful in clinical trials, they could produce billions of doses of vaccine next year.
What does vaccine progress mean for the restart of the economy?
Pfizer and BioNTech are already anticipating preliminary trial results to be available around this time. Companies making other major vaccine candidates are also predicting that early data will be available by the end of the year. However, given the limited initial supply, the public health department cautions that there won’t be enough vaccine available for the general public until sometime next year (perhaps next summer). This means that precautions such as maintaining social distance and wearing masks will remain important protection for the foreseeable future, the health department said, especially since the cold weather will prompt many people to stay indoors and it will take time to return to a normal productive life. While we wait for drugs and vaccines, we actually need to double up on our protection,” says Lisa Maragakis, an infectious disease specialist at the Johns Hopkins University School of Medicine.
What does this mean for other new coronary vaccines in development?
The results of Pfizer’s analysis bode well for Moderna’s new crown vaccine, which uses a similar mRNA technology, and Moderna expects results from a large-scale trial of its vaccine later this month. Other leading vaccines developed by AstraZeneca, Johnson & Johnson (JNJ) and Novavax Inc. do not use mRNA-based technology, but target the neo-crown protein spine, which is also the target of mRNA vaccines. The companies have launched large-scale Phase III trials and could have results in the coming months. Buddy Creech, director of the Vanderbilt Vaccine Research Program in Nashville, Tennessee, said in an interview, “This seems to be proof in principle that we can make vaccines that can bring about an immune response, and from the studies so far, vaccination seems to be safe for individual subjects, proving that it is possible to protect against neo-crown in the real world. “All your visions of a vaccine are here. And it’s encouraging that this vaccine is coming so quickly and with such rigor.
What don’t we know yet?
Efficacy data published by Pfizer and BioNTech are optimistic, but these are only preliminary results. There are many unknowns beyond whether the vaccine is safe to use. The results of the vaccine analysis are just now becoming available, and researchers haven’t had enough time to determine how long the protection afforded by the vaccine will last; the data only looked at the effects of the vaccine seven days after the subjects’ second dose. Gregory Poland, director of the vaccine research group at the Mayo Clinic, says, “What will the vaccine do over time? “Will it be as effective as the flu vaccine for just a few months? Or lifelong immunity, like measles or smallpox? Another unknown is the usefulness of the vaccine to protect against neo-coronitis. It’s also unclear whether the vaccine works for all populations, which includes the elderly, children, and all races and ethnicities. Pfizer and BioNTech are expected to release more data at a later date.
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