We don’t have to live like this forever, with the masks, social distancing, separation from family and pervasive fear and strain.
Just until sometime in the first half of next year.
That’s when several COVID-19 vaccines will become widely available, vaccines that can block an estimated 95 % of new infections.
Some people — like doctors and nurses and paramedics — will likely get the first rush of vaccines in December — most likely based on the brand new, surprisingly effective technology at the heart of vaccines produced by Pfizer and Moderna.
But even if the sparkling preliminary results from large-scale Phase II clinical trials hold up — the public health system faces daunting challenges in distributing the hundreds of millions of doses needed to tame the currently uncontrolled pandemic.
High risk, essential workers could get the vaccine by the end of this year, but mass distribution probably won’t come until April or beyond.
The pandemic has surged as people have increasingly ignored mask wearing, social distancing and business restrictions. The US now has 11 million cases and 246,000 deaths — with a million new cases in just six days.
Apache and Navajo counties have among the highest infection rates in the state as we head into a new peak. The Navajo Reservation has gone back onto lockdown and schools that opened up are trying to decide whether to shut down again as new cases crop up.
This week, Moderna actually topped the recent release of surprisingly strong preliminary results by Pfizer, which has been testing the vaccine on 40,000 volunteers. The Moderna trial involved 30,000 people. Both vaccines reported a 95% level of protection. Those who did get infected despite having the two-dose vaccine had only mild cases. Both the Moderna and Pfizer vaccines had only minimal side effects in some patients, including a sore arm, fever, fatigue and muscle aches that last for a day or two.
Both vaccines proved equally effective in protecting people over 65 – an especially vulnerable population for whom many other vaccines are less effective. In Arizona, those over 65 years old accounted for just 11% of the cases but 71% of the deaths from the virus.
The Moderna vaccine — based on the same, never before used, messenger RNA technology — must be stored at just negative 5 F, compared to negative 80 for the Pfizer vaccine — which should make it easier to distribute.
An independent panel of experts reviewed the preliminary results for both vaccines, which haven’t yet been published in a peer-reviewed journal.
The Moderna vaccine was developed in partnership with the National Institute of Allergy and Infectious Diseases headed by Dr. Anthony Fauci, who pronounced the results much better than he expected.
Moderna reported that 95 people in the Moderna test got infected by the coronavirus. Five of those infected had been vaccinated and none developed serious disease. Ninety people in the placebo control group got infected and 11 of them had severe symptoms. The difference in infection rates accounts for the estimate the vaccine will prevent 95% of infections.
In the Pfizer trial, out of 170 COVID-19 cases 162 were in the placebo group and eight in the vaccine group. Out of 10 severe cases, only one person received the vaccine with the rest getting the placebo.
The vaccine had no serious side effects. About 4% reported fatigue and 2% reported a headache. Older adults actually reported fewer side effects.
The effectiveness in older adults was especially heartening. Older people often don’t respond nearly as well to a vaccine as younger people, due to changes in their immune systems. Older people have fewer immune system cells that specialize in recognizing new threats and often develop a difficult inflammatory response. A poorly understood inflammatory response to the coronavirus helps explain why those older than 65 in Arizona account for just 11 % of the infections but 71% of the deaths.
The trials so far don’t indicate how long the immunity will last — although laboratory studies point toward lasting immunity — perhaps even requiring just one set of shots in a lifetime.
The trials so far also don’t indicate whether the vaccines will also prevent people from passing the virus along even if they don’t have symptoms, but it seems likely that it would. One reason the virus has so far eluded control efforts is that 30% or 40% of those infected don’t even know they’ve contracted the virus and so take no measure to prevent spreading it.
Researchers say it will require months of additional trials to be certain how long immunity lasts and whether it prevents the virus from spreading even if a person doesn’t get sick.
The success of the first two vaccines to near the end of Phase III trials provides solid hope that the pandemic may be tamed early next year – providing people are willing to get vaccinated. Another dozen U.S. vaccines are in the midst of Phase III trial, most based on other technologies. However, the Moderna and Pfizer trials showing that a strong, immediate antibody response does correlate with strong protection could speed up those other trials.
Russia and China have both also released vaccines after much less extensive testing for safety and effectiveness. Doctors in those countries say the vaccines are also better than 90% effective, but some experts are skeptical based on the lack of phase III testing. The vaccines use a different, older technology than the Moderna or Pfizer vaccines.
However, the public health system faces an almost unprecedented challenge in developing a mass vaccination program — especially given the delicate nature of the two mRNA based vaccines at the front of the pack.
The Moderna and Pfizer vaccines work by getting muscle cells to take up the viral RNA that has the genetic blueprint for making the coronavirus’ spike protein, which enables the virus to latch onto the cells it infects. The human muscle cells start producing the viral spike protein. The immune system recognizes that protein and produces antibodies to mark the proteins for destruction by the killer cells of the immune system. This puts the immune system on alert for when the virus does show up. The mRNA vaccine doesn’t not rely on a complete copy of the virus, so it can’t cause the disease and appears to have only minor side effects. Moreover, the mRNA vaccines are easier and faster to manufacture.
No mRNA-based vaccines have ever been approved or marketed before now.
But there’s a catch. Both the Moderna and Pfizer vaccines require two shots, three or four week apart. This doubles the challenge of vaccinating the whole population. Worse yet, they both require extreme cold when they’re transported or stored. This makes the vaccine much more demanding to distribute.
Fortunately, the Moderna vaccine appears more hardy than the Pfizer vaccine, especially when it comes to storage and distribution, according to a summary of the preliminary results in the science magazine Nature.
The Moderna vaccine can remain viable in a regular refrigerator for 30 days and at room temperature for 12 hours. That’s substantially better than Pfizer’s shelf-life, based on Moderna’s patented fatty covering in which the mRNA is stashed.
The Pfizer vaccine would likely require special freezers to keep it cold enough if it’s not injected almost as soon as it arrives at the doctor’s office. The Moderna vaccine is likely more flexible. However, either vaccine would have serious limitations for use in hot countries without sophisticated medical infrastructure.
The US Government through Operation Warp Speed has contracted to buy hundreds of millions of doses of vaccines approved by the federal Food and Drug Administration. Moderna has said it would charge $32 to $37 per dose, with two doses necessary for protection. Moderna got nearly $1 billion government funding and has a contract with the US to provide 100 million doses for $1.5 billion. The government’s contract guarantee would enable it to buy the vaccine for $24.80 per dose.
Pfizer did not take any government money to develop its vaccine, but Operation Warp Speed has promised Pfizer $2 billion for 100 million doses — which works out to about $19.50 per dose, according to the Nature summary. Pfizer says it can produce 50 million doses by the end of the year and 1.2 billion doses by the end of next year.
Moderna has never marketed a vaccine before, but says it can produce 500 million doses in 2021.
Moderna has said it would have 20 million doses ready by the end of the year — enough to vaccinate 10 million people.
Pfizer has promised the US enough vaccine by the end of the year to inoculate 12.5 million people.
So those two companies could produce enough vaccinations for roughly 10% of the US population by the end of the year. That would be enough to vaccinate all the nurses, doctors, teachers and nursing home residents — with 10 million doses left over for other high-risk groups.
However, most public health departments at this point don’t have the capacity to distribute vaccines on such a massive scale. Federal stimulus bills enacted so far provide only a fraction of the billions needed by public health departments in each county to get the vaccine out to doctors offices, mass vaccination shots, clinics and other locations.
Experts also worry that the politicization of the pandemic may complicate efforts to convince people to get the vaccine once it becomes available. The US already has a lively anti-vaccine movement, which has helped measles and other diseases make a comeback despite the existence of safe and effective vaccines.