Biden Plans to Crush COVID-19
As much of the USA awaits vaccines, variant COVID-19 mutations swirl the globe. President Joe Biden’s plan to tackle the pandemic year will hinge on his ability to bulk up the nation’s ability to test for the coronavirus – a massive undertaking that will require cash and industry cooperation.
Biden has laid out a $50 billion plan that would boost America’s testing capacity through the increase of rapid antigen tests, testing centres, expand lab test processing, provide uniform guidance for in-school COVID testing and establish a national pandemic testing board.
Some experts urged Biden to commit a large portion of his $50 billion to rapid antigen tests. Though not as specific as the “gold standard” PCR, they have a higher throughput ability and at lower cost. ABC News said that he would propose as much as $20 billion be put toward investment in rapid testing.
As Biden’s plan seeks to expand the usage of rapid tests, some debate still lingers among diagnostics experts over whether rapid tests might risk producing false negatives at a higher rate. But, experts said there’s no perfect test and widespread surveillance will be an important tool in stopping the spread. Easy access to testing has faced serious issues of inequitable distribution and inconsistent price points over the course of the pandemic.
“There are situations where in parts of this country there’s not the luxury of having PCR testing,” El-Sadr, a professor of epidemiology and medicine at Columbia University Mailman School of Public Health, added.
Pfizer-BioNtech Vaccine for COVID-19
Press release about the preliminary results from the Pfizer-BioNTech vaccine trial came out in early November. They had enrolled 43538 participants in this randomized blinded trial. Early on in the trial, scientists did some calculations and decided that when they had learned that 94 confirmed COVID-19 cases had occurred, they were going to look at the data. They looked for how many of these patients who got COVID-19 have received the placebo vs. had received the actual vaccine. Based on the data from those first 94 confirmed cases of COVID-19, they were able to conclude that the vaccine was found to be > 90% effective in preventing COVID-19 in participants without evidence of prior SARS_CoV-2 infection in this analysis. To be ethical, they need to continue the study to go up to 164 confirmed cases to see if this holds. Vaccine manufacturers, Pfizer-BioNTech say it’s effective at preventing COVID-19 at around 90% when checked at the first checkpoint. Checkpoints calculated from static endpoints measured 7-10 days after the second vaccine dose, so at 28 days after the first vaccine dose. In the trial, study subjects were asked to contact the site coordinator if they had any symptoms of COVID-19 where they were assessed and given a COVID-19 rt-PCR test.
What’s interesting is that there are no asymptomatic subjects in this result cohort. We don’t know what the vaccine does to asymptomatic patients. Furthermore, we don’t know how long the immune effect lasts either. Those will be questions that have to be answered down the line.
Data monitoring committee reported that there were no serious safety concerns. But does the vaccine prevent people from getting the disease COVID-19? Or does it stop infection with SARS-CoV-2 or does it stop vaccinated people from developing COVID-19. That is an especially important point because if it doesn’t stop infection then one can still infect people with the virus. However, if it has a sterilizing effect then it’s potentially possible that it could block the spread of the disease. Meanwhile, rapid antigen testing with social distancing measure have to remain in-place.
We do not have this in a peer reviewed publication yet. In terms of what’s going on biochemically inside these people who get this vaccine is remarkably interesting as it’s a novel approach to creating a defense immune reaction. In published pre-trial studies they found the vaccine lead to rise in neutralizing titers 10 to 18 times that of the SARS-CoV-2 compared to human serum taken from convalescent patients. Not only that, but they found the immune response generated diverse which could substantiate and one whether this is the reason why it seems, at least on preliminary data, this vaccine is 90% effective.
Production & Cost
Pfizer believes that they should have about 50million doses by the end of the year and they’re working right now to try to get emergency use authorization from the FDA. They also say that they should have about 1.3 billion doses by next year. We should realize that this vaccine protocol involves two doses spaced 2 weeks apart. Both doses need to be refrigerated in special freezers that keep them at -70CPfizer are saying that vaccine cost will be about $38.00.
FDA Approves COVID-19 Self Test Home Kit
In the United States, the Food and Drug Administration (FDA) has issued an emergency use authorization for the first home use self-test for Covid-19 which like DropTech, can provide rapid SARS-CoV-2 detection results in a few minutes. The FDA’s Health and Human Services Secretary Alex Azar said in a statement “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options”.
The single use COVID-19 test kit is a rapid antigen detection test (RADT) made by a US based company Lucira. CNN revealed the test is available by prescription for self-diagnosis of the coronavirus.
In a statement by the FDA, “the test employs molecular amplification technology to detect the virus in people with known or suspected Covid-19 and can return results in 30 minutes”. It identifies molecular coronavirus genetic material.
FDA Commissioner, Dr Stephen Hahn said in a statement “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,”
The new Lucira test, like DropTech, uses self-collected nasal swab samples. The FDA authorization allows for use in people 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider. The test is also authorized by the FDA for use in point-of-care settings, such as doctor’s clinics, hospitals, urgent care centers and accident and emergency rooms for all ages but in these settings it must be collected by a health care provider, the FDA said. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn added.