20 November 2020 Post: Update for Patients, Expect a Shelter-in-Place Order

20 November 2020 Post: Update for Patients, Expect a Shelter-in-Place Order

Update for Patients: Expect a Shelter-in-Place Order As early as this weekend, Los Angeles residents should expect another round of shelter-in-place orders. Los Angeles recorded its highest number of daily new COVID-19 infections ever on Thursday at 5,031. If the five-day case average reaches 4,500 or more, or if hospitalizations top 2,000 per day, the county will re-implement its original Safer At Home order for three weeks, allowing only essential workers to leave their homes, or residents seeking out essential services. I have every expectation that we will reach that 5 day average threshold. Visiting our office does remain an essential service but for those patients who are uncomfortable being in a medical office during a case surge, please feel free to reschedule appointments. We do see patients both in telemedicine and via video conferencing modalities. We intend to remain open and have strict protocols in place – ensuring distancing between patients in time and in distance. We screen all patients at their visits with rapid antigen testing. All patients with COVID-19 symptoms or an exposure history to a known case can have testing curbside next to our building – as we have done since March. For further details on the mitigation efforts we have put in place in our office please link to: https://drbretsky.com/covid-19-overview-of-our-response-to-the-pandemic/

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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19 November 2020 Post: COVID-19 Update in Los Angeles – Bad to Worse

19 November 2020 Blog: COVID-19 Update in Los Angeles: Bad to Worse

COVID-19 Update in Los Angeles: Bad to Worse One of the more useful analogies I read about the community spread of COVID-19 came from Trevor Bedford, a computational biologist at the University of Washington. In early March he described each small cluster of cases as an ember in a windstorm. Some stay in place, some get caught in the wind but flare out. Others, however, flare up and spread – igniting fires as they go along, each of which on their own produce more embers. The difficulty with letting an epidemic smolder, as we did in Los Angeles County from August through October, is that you give it space, oxygen and fuel to explode. This is precisely what has happened and, this week, our case rates exceeded those we saw in mid-July. The upward slope of the curve is shocking (Figure 1 below).Β 

We now stand at 30.17 new daily cases per 100,000. The previous maximum was 29.60 the week of 7/14/2020. The last time we had an acceleration of cases (granted it was nowhere near this steep), it took over 6 weeks to begun to flatten out and turn the corner. Six weeks from now is the first week of January 2021. Public health advice from the County has been muted. Restaurants have been asked to cut patronage by 50% and to close between 10pm and 6am. Outdoor gatherings are to be limited to three households or fewer. Once again, our health officials are not acting decisively. Patients have asked me for practical advice and here it is: 1. Cancel your Thanksgiving plans 2. Cancel your Christmas or seasonal Holiday plans 3. Cancel your New Years plans 4. Don’t travel 5. Don’t expect school to open in January 6. Do expect another round of shelter-in-place 7. Count ourselves fortunate that COVID-19 treatment modalities have significantly improved over the past several months 8. Count ourselves fortunate that vaccines are on the horizon (but practically will not be available until late Spring, early Summer) Also available on: drbretsky.com/blog

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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12 November 2020 Post: COVID-19 Office Update

12 November 2020 Post: COVID-19 Office Update

With cases surging in Los Angeles County, the steps taken in medical facilities and offices are more critical now than ever. Population prevalence is the primary determinant of community spread and your individual risk of infection.
Β 
Almost uniformly, I have been told by patients that the infection control steps we take in our office are unlike any other they have seen. We base our approach on basic principles of distancing (both in time and in space) as well as active surveillance (testing).
Β 
For more details on how our office has responded to COVID-19 and what you can expect at an office visit, please visit:

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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11 November 2022 Post: COVID-19 Vaccine Distribution and Cold Chain Challenges

11 November 2020 Post: COVID-19 Vaccine Distribution and Cold Chain Challenges

Following up on yesterday’s Blog Post about the Pfizer and BioNTech announcement of a vaccine with a preliminary 90% efficacy, we now turn to the challenges of distribution. I mentioned that the vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below in order to maintain its integrity.

An outstanding article today in ProPublica (link below) highlights the fact that most states lack the resources and infrastructure to deliver the vaccine to their communities. Here are the litany of steps needed to transport and administer the vaccine:

  1. Needs to be stored at temperatures of about minus 100 degrees Fahrenheit
  2. Will be delivered in dry ice-packed boxes holding 1,000 to 5,000 doses
  3. Doses viable for up to 10 days
  4. Ice can be replenished up to three times
  5. Once opened, the packages can keep the vaccine for five days
  6. Packaged can’t be opened more than twice a day
  7. The vaccine can also survive in a refrigerator for five days but can’t be refrozen if unused

Needing to use 1,000 doses within a few days may be feasible for large hospital systems (note that Mayo Clinic which is among the preeminent hospitals in the US does not have capacity to store this vaccine), it is impossible for physician offices to manage these requirements. According to the linked article, distribution is β€œespecially challenging in smaller towns, rural areas and Native communities on reservations that are likely to struggle to administer that many doses quickly or to maintain them at ultracold temperatures.”

According to ProPublica, who obtained full preliminary plans for 47 states, there were clear struggles with how to handle this vaccine. Some states do not have adequate warehousing with temperature control, others cannot feasibly expect to distribute to rural communities, tribal lands or migrant workers. Other states cannot account for the large volume (1000-5000 doses) and can only manage smaller numbers.

@cdc Director Robert Redfield has said Congress will need to provide up to $6 billion but only $200 million has been allocated to this process.

Fortunately, we are not solely reliant on a single vaccine modality. In fact, I am hopeful that those efforts moving more slowly than Pfizer, such as Johnson and Johnson, will have more practical utility for the US population. This vaccine has far less stringent storage requirements and is given as a single dose, rather than two separated by 21 days. Following their efficacy data along with other efforts could lead to a multi-layered approach that would go far to bring this pandemic finally under some semblance of control.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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10 November 2020 Blog Post: Pfizer SARS-CoV-2 Vaccine Results

10 November 2020 Blog Post: Pfizer SARS-CoV-2 Vaccine Results

Today Pfizer announced encouraging results of its SARS-CoV-2 vaccine co-developed with BioNTech. It demonstrates an efficacy above 90% at 7 days after the second dose is given, according to interim results from the companies’ phase 3 trial. The trial has enrolled roughly 44,000 volunteers, 39,000 of whom have received both doses. The final analysis will occur after 164 cases of COVID-19 have been confirmed. In the interim analysis, 94 cases have been diagnosed. The vaccine monitoring committee has not identified any serious safety concerns.

So what does this all mean?

The study originally began with Phase 1 and Phase 2 dosing, safety and efficacy trials before moving into its current Phase 3 or final study stage. Initially in Phase 1 there were two RNA vaccine candidates developed by BioNTech – one directed at the receptor binding protein of the novel coronavirus and the other directed at its well described β€œspike protein”. It is important to note that there has never been until now an RNA vaccine. The vaccine candidate selected for Phase 2/3 evaluation was the spike protein at a dose of 30 Β΅g.

The candidate vaccine is a two shot series with each injection separated by 21 days. According to today’s press release, Β the evaluable case count reached 94 and the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose – or 28 days from the first dose. They did not release the number of cases seen between the treatment and placebo group. Those numbers will be helpful to see as will the distribution of severity of disease. Ideally, one would hope that a vaccine would prevent severe cases of COVID-19.

While these results are certainly encouraging, distribution of the vaccine itself has a major obstacle – namely its super-cold storage requirements. The vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below. This is an obstacle for even the most sophisticated hospitals in the United States (in fact Mayo Clinic does not have this capability) and therefore will significantly limit when and where it is available. California has already said it will not provide vaccine supplies to facilities without adequate cold-storage capabilities.

This concern aside, FDA regulators will soon deem whether the vaccine is a reasonable candidate for widespread use. Pfizer said it would seek an emergency use authorization from FDA around the third week of November, at which point participants will have been followed for an average of 2 months β€” an FDA safety requirement for COVID-19 vaccines.

𝗦𝗢𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 π—’π˜‚π—Ώ π—‘π—²π˜„π˜€π—Ήπ—²π˜π˜π—²π—Ώ

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