Just as Americans were gearing up for the busy holiday season, the Omicron coronavirus variant took the nation by
storm.
Omicron is spreading very rapidly
In countries around the globe, already ringing in the new year, many deciding to cancel their celebrations with the
latest Omicron outbreak.
Carriers cancel another fifteen hundred U.S.
flights today, more than 3000 delayed.
We're already up to over eight hundred thousand deaths in the US during the pandemic and I'm really concerned with the
level of hospitalizations
While the U.S. has been well equipped with vaccines, boosters and treatments to tackle the latest wave, one tool
has been noticeably absent from its arsenal at home COVID tests
In the U.S., there really hasn't been a home testing strategy rolled out, and really the role of home testing was
discussed in a very limited way.
Now, when it comes to rapid tests, we have seen the supply of them increase over the last few months, but they are
getting increasingly difficult to find as well.
We should have been ahead of the testing game and unfortunately, we're always two steps behind.
We've had an unprecedented demand with Omicron and then a lot of travel.
Here's how the U.S. fell behind on its at home COVID testing strategy and what's being done to fix it.
When it comes to diagnosing COVID-19, there are two main types of tests.
The PCR test is kind of our gold standard test.
That test goes through a laboratory and it takes several hours to get a result.
The other tests that we have is the rapid antigen test and that can be done at a health care facility or a testing
site. Also, it can be done at home
So PCR tests have the advantage of being very sensitive.
People think of the rapid antigen tests as being really good markers for contagiousness because they are only
going to be positive if you have enough virus in there to trigger the limits of detection on the test.
The Biden administration has made it clear that rapid tests will be critical when it comes to reopening the U.S.
economy. Back in January 2021, the president's National Pandemic Strategy called for a major unified federal
investment in rapid tests to help reopen schools, businesses and travel.
More than a year later, buying an at home test at your local drugstore remains a challenge.
The issue of how frequent, when and how frequently you have to test is really a critical issue for these rapid tests.
Right now, we're at the peak of the Omicron wave.
The risk is high. People are going to have to test more frequently.
The lack of easy access testing could be a problem.
The country's vaccination rate has stalled, leaving pockets of Americans vulnerable to severe outcomes.
Experts also point out that kids under the age of five still don't have access to an authorized vaccine.
Even vaccinated Americans are testing positive for COVID-19, and researchers are trying to understand what that
means for how well the virus spreads.
What we're seeing is our vaccines are not transmission blocking.
They may reduce the probability of someone getting infected.
They reduce the probability that someone who's vaccinated, who's infected can transmit the virus to people in their
households and the community.
And that's really important.
If you live in the UK, you could order a pack of seven rapid COVID tests in a single day for free.
At-home tests only cost a few dollars at German grocery stores.
But in the U.S., prices are on the rise.
There are two challenges that lead to some of the price issues that we see in the United States.
One could be some of the failure to have these upfront purchasing agreements with the manufacturers.
And then the other piece could be that there are fewer manufacturers, there are fewer diagnostic companies in the
U.S. space.
Abbott Laboratories and Quidel were among the first manufacturers to secure FDA authorizations for their
over-the-counter tests, according to preliminary earnings from Quidel, the company sold $510 million in COVID-19 tests
during the fourth quarter.
That's up roughly 27 percent from the previous quarter.
Abbott said it sold $2.3 billion worth of COVID tests during its fourth quarter, up roughly 21 percent from the
previous quarter. Abbott says it has shipped one point four billion tests since the pandemic began.
I think maybe the emphasis has been on vaccines for the administration, and I wish that there had been
more put onto rapid antigen tests, but there was a lot of effort put into testing generally.
It just was in specific context, like there was money made available for schools to be able to set up testing
programs.
Federal regulators at the FDA have been ridiculed for not authorizing at-home COVID tests quickly enough to match
demand.
There's been some criticism that the FDA standard for these tests is set at too high a bar.
So the FDA's response to the criticism that their standards are too stringent is that they might not want to approve a
test that's approved elsewhere, authorize a test that's on the market elsewhere that for them, ensuring that these
tests are a really high standard is the most important piece.
The pushback against that would be that these tests shouldn't be judged against a PCR test.
They should be judged on their own or through a different set of standards, and they have a different utility.
The CDC's evolving testing guidance for the vaccinated has also confused suppliers.
In March of 2021, the agency relaxed recommendations for vaccinated Americans as more people gained access to the
shots. If you were vaccinated, the agency said, you no longer needed to get tested after being exposed to someone
infected with COVID-19.
As testing demand dwindled, manufacturers began to ramp down production.
In July, Abbott slashed hundreds of jobs at its production sites amid a significant rapid decline in testing demand.
Abbott told CNBC that it's rehired for some of those positions, with the aim of producing 100 million tests a
month. Abbott said those tests will support federal, state and local governments, as well as employers, schools and
retail.
We looked at some of the federal financial documents that manufacturers filed.
We found them saying, 'Look, the CDC is saying that if you're fully vaccinated and you've had a close contact, you
don't need to test.' And there was a clear correlation between that and the manufacturers feeling like, 'Well, we
can't build up this huge supply if vaccines are rolling out and they're going to be widely available.
And if there's a large uptake, there may just not be a demand for these tests.'
And then Delta hit and then people want to test again and school started going back into session.
People want to test for that.
And so all of a sudden, there are no tests on the shelves.
The COVID-19 vaccines have been found to hold up against the Delta and Omicron variants.
By early August, as schools are turned in offices reopened, the CDC reworked its guidance to recommend even fully
vaccinated people get tested after a COVID exposure or before holiday gatherings.
It's a bit of a perfect storm.
You had people going into the holidays where they were quite likely going to engage with people from outside their
household. You had Omicron surging, so we had this more infectious variant and then you
had a shift in federal guidance, but also media coverage.
And so together, all of these things, I think, really drove awareness of and desire for home testing.
The acute shortage in at home test has prompted the federal government to take a number of steps to boost supply and
ease costs. In November, regulators at the FDA streamlined the process for authorizing at home COVID tests.
So without changing these metrics too much, the FDA has taken steps to try and
make the U.S. regulatory environment more friendly to manufacturers, and this is happening in a few ways.
So first, working collaboratively with NIH and CDC, the federal government is
seeking manufacturers with tests available outside the United States and exploring whether those diagnostic
companies would want to come in and seek U.S.
authorization. The FDA has also said that they're prioritizing review of certain tests, and that includes home
tests and particularly home tests for manufacturers with the ability to scale up.
The administration struck agreements worth $3 billion in the fall to help bolster staffing, add production lines and ramp
up supply. That investment is starting to pay off.
The White House expects three hundred and seventy five million at home tests will be on the market by the end of
January, up from the year twenty four million available in August.
The U.S. intends to buy one billion at home tests that Americans can order directly through a government website
free of charge. On top of that, private insurers and group health plans are required to cover the costs for up to eight
over-the-counter tests per person per month.
But the question remains, will that be enough?
There's substantial supply coming into the market, Abbott's talking about producing up to a million tests per month.
And I think with respect to trying to make them available to consumers, it's still cumbersome to to purchase this
test, if you can find it and file an insurance claim.
I think we really should be in the setting of these, these waves of infection when we know that we want more people to
be doing routine testing, we really need to find ways to push them out to consumers.
Consumers who are going to seek out the tests and file an insurance claim aren't the ones who are having trouble
getting access to the tests. It's the ones who aren't going to be able to find the time to do that.
In the United States, we haven't had federal guidance on how to make testing a regular part of your daily life or your
daily week. A comparison is the U.K., where it's recommended people over 11 test
twice a week. And in the U.S., if everybody over 11 tested twice a week, we would need two point three billion tests
per month. And we're not there.
As we've seen the virus continue to evolve, we've seen what happens with these variants.
So I think all of the testing companies have to continue to have capacity available because we don't know what's going
to happen this time next year.