FRANKFORT, Ky. (LEX 18) Gov. Beshear has announced his son, Will, tested positive for COVID-19.
The governor says he's doing fine and is fully vaccinated. He also recently received his booster shot. The rest of the family tested negative.
28,857 new cases were reported between Saturday and Monday. 76 more Kentuckians died from the virus during that time frame. The state's current positivity rate is 33.06%.
Kentucky Public Health Commissioner Dr. Steven Stack says omicron appears to not attack the lungs as hard as previous variants, meaning there are enough ventilators to go around. However, there is a surge of healthcare workers getting COVID-19 and not being able to work.
64% of Kentuckians 65 and older have been boosted. 42.5% of Kentuckians 18 and older have been boosted.
Total vaccine doses distributed: 659,895,815
Patients who've received the first dose: 250,763,600
Patients whove received the second dose: 210,358,008
% of population fully vaccinated: 63.4%
% of infections tied to the Omicron Variant: 99.5%
% of infections tied to the Delta Variant: 0.5%
Updated 21 January 2022, pursuant to updated interim recommendations
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the Pfizer BioNTech (BNT162b2) vaccine against COVID-19. This article provides a summary of those interim recommendations; you may access the full guidance document here.
Here is what you need to know.
According to SAGE, the Pfizer-BioNTech COVID-19 mRNA vaccine is safe and effective. The priority is to start vaccinating health workers at high risk of exposure, followed by older adults, before immunizing the rest of the population.
Who should be vaccinated first?
While vaccine supplies are limited, it is recommended that priority be given to health workers at high risk of exposure and older people, including those aged 65 or older.
Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritization of target groups.
Who else can take the vaccine?
The vaccine has been found to be safe and effective in people with various conditions that are associated with increased risk of severe disease.
This includes hypertension, diabetes, asthma, pulmonary, liver or kidney disease, as well as chronic infections that are stable and controlled.
Given the significant risk of severe COVID-19 for moderately or severely immunocompromised persons (ICPs), WHO advises an extended (3 dose) primary series based on available data, though individual safety monitoring is required, as is consultation with the treating physician.
Persons living with HIV are at higher risk of severe COVID-19 disease. Limited safety data exists on HIV-infected persons with well controlled disease from the clinical trials. Known HIV-positive vaccine recipients should be informed, and when possible, counselled in relation to the available data.
Vaccination can be offered to people who have had COVID-19 in the past. But given the limited vaccine supply, individuals may wish to defer their own COVID-19 vaccination for up to 6 months from the time of SARS-CoV-2 infection. However, consideration should be given for circulating variants of concern. In such settings, earlier immunization after infection is advisable, e.g. within 90 days following natural infection.
Vaccine effectiveness is expected to be similar in breastfeeding women as in other adults. WHO recommends the use of the vaccine in breastfeeding women as in other adults. WHO does not recommend discontinuing breastfeeding because of vaccination.
Should pregnant women be vaccinated?
Given the adverse consequences of COVID-19 disease during pregnancy and the increasing data supporting a favorable safety profile of BNT162b2 in pregnancy, WHO recommends the use of BNT162b2 in pregnant individuals. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.
Who should not take the vaccine?
People with a history of severe allergic reaction to any component of the vaccine should not take it.
Is this vaccine recommended for children and adolescents?
This vaccine is safe for use for those aged 5 and above, with an adjustment in the recommended dosage for those aged 5-11.
A Phase 3 trial in children aged 12-15 years showed high efficacy and good safety in this age group, leading to an extension of the previous age indication from 16 years down to age 12 and above. A Phase 3 trial in children aged 5 -11 showed similar immune response and safety results.
WHO recommends that countries should consider using the vaccine in children aged 5 to 17 only when high vaccine coverage with 2 doses has been achieved in the high priority groups as identified in the WHO Prioritization Roadmap.
Children and adolescents aged 5-17 years of age with comorbidities that put them at significantly higher risk of serious COVID-19 disease, should be offered vaccination, alongside other high-risk groups.
What is the recommended dosage?
A protective effect starts to develop 12 days after the first dose, but full protection requires two doses which WHO recommends be administered with a 21 to 28-day interval. Additional research is needed to understand longer-term potential protection after a single dose. It is currently recommended that the same product should be used for both doses, when possible.
SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine, as part of the primary series. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary vaccination series and are at higher risk of severe COVID-19 disease.
Studies have shown a high public health impact where the interval has been longer than that recommended by the EUL. Accordingly, countries facing a high incidence of COVID-19 combined with severe vaccine supply constraints could consider delaying the second dose up to 12 weeks in order to achieve a higher first dose coverage in high priority populations.
Is a booster dose recommended for this vaccine?
A booster dose may be considered 4 6 months after completion of the primary vaccination series, though this is mainly recommended for the higher priority-use groups, in accordance with the WHO Prioritization Roadmap.
The benefits of booster vaccination are recognized following increasing evidence of waning vaccine effectiveness against mild and asymptomatic SARS-CoV-2 infection over time.
The need for, and timing of, booster doses for children aged 5-11 years has not yet been determined.
Can this vaccine be mixed and matched with other vaccines?
SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series.
For countries considering heterologous schedules, WHO has made recommendations to ensure equivalent or favourable immunogenicity or vaccine effectiveness for heterologous versus homologous schedules:
Either of the WHO EUL COVID-19 vectored vaccines (Janssen or AstraZeneca Vaxzervia/COVISHIELD) can be used as a second dose following a first dose of the Pfizer vaccine, dependant on product availability.The Pfizer vaccine can also be used as a second dose following any of the WHO EUL COVID-19 inactivated vaccines (Sinopharm, Sinovac or Bharat) or any of the vectored vaccines (Janssen or AstraZeneca Vaxzervia/COVISHIELD)
Is it safe?
The Global Advisory Committee on Vaccine Safety (GACVS), a group of experts that provides independent and authoritative guidance to WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international impact. In October 2021, the GACVS COVID-19 subcommittee concluded that the mRNA COVID-19 vaccines have clear benefits in all age groups in reducing hospitalizations and deaths due to COVID-19.
How efficacious is the vaccine?
The Pfizer BioNTech vaccine against COVID-19 has an efficacy of 95% against symptomatic SARS-CoV-2 infection.
Does it work against new variants?
SAGE has reviewed all available data on the performance of the vaccine in tests to assess efficacy against a variety of variants. These tests indicated that the vaccine was effective against virus variants, though for the Omicron variant, vaccine effectiveness against severe and mild disease after two doses is lower compared to Delta, and waning is more rapid.
SAGE currently recommends the use of the Pfizer BioNTech vaccine according to the WHO Prioritization Roadmap, even if virus variants are present in a country. Countries should assess the risks and benefits taking into consideration their epidemiological situation.
Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. As new data become available, WHO will update recommendations accordingly.
Does it prevent infection and transmission?
There is currently no substantive data are insufficient evidence available related to impact of Pfizer BioNTech vaccine on transmission or viral shedding.
In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation
How does this vaccine compare to other COVID-19 vaccines in use?
It is impossible to compare vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.
This webpage was updated on 19 January 2022 to include the latest guidance.
This webpage was updated on 5 January 2022 to update the latest guidance and ensure consistency of information and formatting.
This webpage was updated on 20 April 2021 to ensure consistency of information and formatting.
This article was corrected on 12 January 2021 to remove an erroneous reference relating to pregnancy. WHO does NOT recommend that pregnancy be avoided post-vaccination.
It's been well over a year since a landmark proposal brought the issue of patent waiver for the mRNA Covid vaccine to the spotlight. But many observers don't see that waiving the intellectual property (IP) rights on Covid vaccines is an effective way to put a stop to the pandemic.
Supporters of patent waivers like Harsha Thirumurthy, associate professor of medical ethics and health policy at the University of Pennsylvania, argue the issue lies at the heart of the reason why vaccines are less accessible in lower-income countries.
"It limits how much manufacturing there can be of that product or that vaccine," said Thirumurthy, adding it keeps the price "artificially high enough that it limits the ability of other countries in the world."
But critics counter that patent waivers will not automatically lead to an improvement in global vaccine distribution.
Microsoft co-founder Bill Gates was among those who originally spoke out against the patent waiver, emphasizing that there are problems beyond patents that must be addressed first. Gates later reversed his stance and is now in full support of temporarily waiving the protections over coronavirus vaccine patents.
"Having a billion vaccines sitting in a warehouse of a lab that's developing will do no good getting us back to normal," said Heath Naquin, vice president of government and capital engagement at the University City Science Center, a nonprofit research organization, in Philadelphia.
"The patent waiver itself doesn't actually solve that core issues in many developing countries, which are not related to the recipe, they are related to the way you get that out the door to people."
However, experts on both sides of the debate seriously doubt whether a patent waiver on Covid-19 vaccines will ever come to be.
"I think we had the best hope of it last year when there was a proposal that was put forward at the WTO and the Biden administration had supported it," said Thirumurthy.
"But we had European countries that objected to those patent waivers."
Watch the video to find out more about why vaccine patents exist and the ongoing debate over their impact on the Covid pandemic.
Health care workers in Israel who received a booster dose of the Pfizer-BioNTech COVID-19 vaccine were significantly less likely to contract SARS-CoV-2 than those who received two doses, a recent study found.
The study, published in JAMA, included 1928 health care workers at Tel-Aviv Sourasky Medical Center Israel, between Aug. 8 and Sept. 20.
The median age was 44, and 71.6% of participants were women. All were immunocompetent and had received a two-dose series of the Pfizer-BioNTech COVID-19 vaccine at least one month before study enrollment, and 1,650 (85.6%) received a booster dose.
Overall, 44 participants contracted COVID-19 during the study period, including 39 who hadnt received the booster dose and 5 who had, for an incident rate of 116 per 100,000 person-days compared with 12.8. Compared with those who only received two doses of the vaccine, the adjusted hazard ratio for SARS-CoV-2 infection after booster was 0.07 (95% CI, 0.02-0.20). Of the infections, 31 (70.5%) were symptomatic and 13 (29.5%) were asymptomatic. Infections among participants who werent boosted were more likely to be symptomatic than those among boosted participants (71.7% compared with 60% respectively).
These findings are in line with the reduction in SARS-CoV-2-related hospitalizations across multiple age groups after booster administration reported in a large observational study in Israel, as well as with the reduction in SARS-CoV-2 infections observed after booster administration in persons older than 60 years reported in another Israeli nationwide study, the authors, led by Avishay Spitzer, MD, wrote.
Booster recipients saw an increase in anti-S1-RBD IgG antibody levels starting five days after booster vaccination.
Investigators plan to continue surveillance of participants for a year after enrollment.
These findings clearly indicate that providing another vaccine dose following a 2-dose initial series is associated with both improvement in the immunological response to the vaccine antigen and reduction in the risk of symptomatic and asymptomatic infection, Anna Wald, MD, MPH, wrote in an associated editorial comment.
The US Centers for Disease Control and Prevention has approved emergency use authorization of the Pfizer-BioNTech booster for everyone aged 12 and older at least five months after the primary series.
An important consideration is whether this vaccination is a booster dose or a third dose, Wald wrote, noting that the longer interval between doses could result in a more durable immune response.
The study is among a growing body of research examining the efficacy of booster shots. A recent study from London showed that those who received three shots of Pfizer-BioNTech or AstraZeneca vaccines produced high neutralizing antibody titers against Omicron, Delta and Alpha variants.
In another study, investigators from the Ragon Institute of MGH, MIT and Harvard created a pseudovirus version of Omicron and determined that a third dose of an mRNA vaccine was required to protect against the variant.
GROTON Ledge Light Health District will host a COVID-19 vaccine clinic on Thursday, Jan. 27, from 3 to 5 p.m., at the Groton Municipal Building, 295 Meridian St.
The Moderna vaccine and a limited supply of the Johnson and Johnson vaccine will be available for anyone who is 18 years old or older and needs a first or second dose or is eligible for a booster dose. No appointment, insurance or ID is needed.
In addition, the following vaccination clinics are scheduled in New London:
Wednesday, Jan. 26, 2 to 6 p.m. for ages 12-plus: New London Public Library, 63 Huntington St.; Pfizer 12-plus, Moderna or J&J 18-plus.
Thursday, Jan. 27, 4:30 to 7:30 p.m. for ages 5 to 11 and 18-plus: Jennings School, 50 Mercer St.; Pfizer 5-11, Moderna or limited supply J&J 18-plus.
Saturday, Jan. 29, noon to 4 p.m. for ages 5-plus: McDonalds, 406 Colman St.; Pfizer 5-plus, Moderna or J&J 18-plus
The current booster recommendations are as follows:
For individuals who received the Moderna vaccine, the following groups are eligible for a booster shot:
Severely immunocompromised at one month or more after their initial series.
Everyone age 18 or over at five months or more after their initial series.
For individuals who received the Pfizer-BioNTech vaccine, the following groups are eligible for a booster shot:
Severely immunocompromised at one month or more after their initial series.
Everyone age 12-plus at five months or more after their initial series.
For individuals who received the J&J vaccine, booster shots are recommended for those who are 18 and older and who were vaccinated two or more months ago.
Mixing and matching (heterologous series): Both the FDA and CDC support individuals to receive a booster dose that is a different vaccine type than they originally received for their primary series if they choose. CDCs recommendations now allow for this type of mix-and-match dosing for booster shots.
Visit LLHD.org for more information.
Sun staff
Millions of people around the world have received two shots of Sinovac, a Chinese-manufactured inactive vaccine that is used in 48 countries to help reduce transmission rates of COVID-19.
However, those vaccinations alone are of no help against the widely circulating omicron variant, shows a new study by researchers at Yale and the Dominican Republic. The results are published in the journal Nature Medicine.
An analysis of blood serum from 101 individuals from the Dominican Republic showed that omicron infection produced no neutralizing antibodies among those who received the standard two-shot regimen of the Sinovac vaccine. Antibody levels against omicron rose among those who had also received a booster shot of the mRNA vaccine made by Pfizer-BioNTech.
But when researchers compared these samples with blood serum samples stored at Yale, they found that even those who had received two Sinovac shots and a booster had antibody levels that were only about the same as those whod received two shots of the mRNA vaccines but no booster shot. In other studies, the two-shot mRNA regimen without a booster has been shown to offer only limited protection against omicron.
Also, the researchers found that individuals who had been infected by earlier strains of the SARS-Cov-2 virus saw little immune protection against omicron.
The findings will likely complicate global efforts to combat the omicron strain, which has supplanted the more dangerous but less transmissible Delta strain as the most dominant circulating virus in much of the world. An additional booster shot and possibly two are clearly needed in areas of the globe where the Sinovac shot has been chief source of vaccination, said Akiko Iwasaki, the Waldemar Von Zedtwitz Professor of Immunobiology and senior author of the paper.
Booster shots are clearly needed in this population because we know that even two doses of mRNA vaccines do not offer sufficient protection against infection with omicron, Iwasaki said.
Omicron has proven particularly problematic to combat because it possesses 36 mutations on the spike proteins on its surface, which the virus uses to enter cells, researchers say. Existing mRNA vaccines are designed to trigger antibody response when spike proteins are recognized.
Iwasaki stressed, however, that the human immune system still has other weapons it can use against COVID-19, such as T cells that can attack and kill infected cells and prevent severe disease.
But we need antibodies to prevent infection and slow transmission of the virus, she said.
Reference: Neutralizing antibodies against the SARS-CoV-2 Delta and Omicron variants following heterologous CoronaVac plus BNT162b2 booster vaccination by Eddy Prez-Then, Carolina Lucas, Valter Silva Monteiro, Marija Miric, Vivian Brache, Leila Cochon, Chantal B. F. Vogels, Amyn A. Malik, Elena De la Cruz, Aidelis Jorge, Margarita De los Santos, Patricia Leon, Mallery I. Breban, Kendall Billig, Inci Yildirim, Claire Pearson, Randy Downing, Emily Gagnon, Anthony Muyombwe, Jafar Razeq, Melissa Campbell, Albert I. Ko, Saad B. Omer, Nathan D. Grubaugh, Sten H. Vermund and Akiko Iwasaki, 20 January 2022, Nature Medicine.DOI: 10.1038/s41591-022-01705-6
Carolina Lucas and Valter Silva Monteiro, both from the Yale School of Medicine, are co-lead authors of the paper. Eddy Perez-Then, of the Health Ministry of the Dominican Republic, and Marija Miric, of Two Oceans Health in Santo Domingo, are co-lead authors.
Jens Schlueter/Getty Images News
Last year, Pfizer (PFE) made $36 billion from its COVID-19 mRNA vaccine, while Moderna (MRNA) made $5 billion in the third quarter alone. Pfizer's BioNTech SE (NASDAQ:BNTX) partnered vaccine is the best selling pharmaceutical product of all time in a given year - and Pfizer, at least, has received considerable flak after Albert Bourla, its CEO, called the demand for sharing vaccine recipes as 'dangerous nonsense.' Of course, Bourla's unstated claim that developing countries do not have the expertise to make these vaccines is balderdash, which has been so proven by the very successful Covaxin vaccine developed indigenously by India's Bharat Biotech with technical knowhow from the Indian National Institute of Virology. Although not an mRNA vaccine, Covaxin has very good immunogenic results, and its fridge temperature storage is a blessing for poorer countries because storing in extreme cold is expensive (the Moderna vaccine does not require such low temperatures).
So there's a clear crack/powder dichotomy between the vaccines the richer western countries are getting versus what the RoW is getting. Everybody - except the virus itself - is clearly financially profiling the global vaccine effort. The virus doesn't care how expensive your vaccine is.
In the midst of this dichotomy comes AstraZeneca (AZN) with its traditional non-mRNA vaccine that it has promised to give away at-cost to poorer countries while the pandemic lasts. AZN investors want to understand why the company took this huge charity effort while competitors large and small are raking in billions in vaccine profit. First, here's a pricing chart of current vaccines:
Covid vaccine prices
BBC
AZN is, as we can see, pricing itself at the lowest among peers. How it is able to do so is a mystery. Its November quarter was a mess. Not only was there a 13% EPS miss, but its second guidance for Q4 did not jive well with the consensus, which was well below even the bottom end of its guidance range. See what Bloomberg says about this:
A messy quarter, with a 13% EPS miss but reiterated guidance, suggests AstraZeneca has a cost-phasing issue, and consequently needs to beat 4Q consensus even to make the bottom end of its reiterated range. A slight revenue miss ex-COVID-19 vaccine was driven mainly by Tagrisso, but focus will be on whether the EPS miss is down to a lack of appreciation for the newly-incorporated Alexion cost base or frontloading of launch costs. A reiteration of guidance suggests the latter, though Astra has chosen to incorporate some first-time vaccine profit into guidance, but not amend it.
Clearly, profit-making was a missed opportunity for AstraZeneca. Neither was it a huge marketing achievement. AstraZeneca's vaccine is selling almost exclusively in the poorer countries of the world, and this isn't a segment the company probably intends to focus on with its marketing efforts. Moreover, clotting issues, rare if verified, trial data concerns, and now the belated profit-making, none of these have helped any possible marketing effort. Thus, the question remains, why did Pascal Soriot take the call to sell the vaccine at cost?
"A key element of Oxford's partnership with AstraZeneca is the joint commitment to provide the vaccine on a not-for-profit basis for the duration of the pandemic across the world, and in perpetuity to low- and middle-income countries," Oxford and AstraZeneca said in a statement in early 2020. The company also received funds from Covax and the Coalition for Epidemic Preparedness Innovations (CEPI), possibly under a not-for-profit arrangement. It is interesting that despite the initial burst of charity, the University changed course, see what Fortune magazine said in August 2020:
A few weeks later, Oxford-urged on by the Bill & Melinda Gates Foundation-reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices-with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.
Since the third quarter, AstraZeneca has started making some money from its vast vaccine effort. In the first quarter of last year, it made $275mn, then $894mn in 2Q, and $1.05bn in the third quarter. In the entire year so far, they made $2.2bn from the vaccine. The development began when AZN decided to remove a number of middle-income countries from the list of its not-for-profit beneficiaries. This has caused it to face a lot of criticism, for example this one:
However, Nick Dearden, director of campaign group Global Justice Now, said AstraZeneca's decision to start profiting from the vaccine while the coronavirus pandemic was continuing "shows the utter folly of giving away publicly-funded science to big pharma".
"This moment was always going to come - and it's exactly why public health experts have demanded a waiver of intellectual property on COVID-19 vaccines," he said.
I think this criticism is missing the point. It is true that the entire science was developed through government funding, even the manufacturing was heavily subsidized for even the profit-makers and fully funded for the others. However, there's a reason the government asked Big Pharma to actually make the vaccines - because if it could, it would; but it can't, so it didn't. Big Pharma has done the world a service by enabling vaccine manufacturing and distribution - and now they want to charge for it. That, at least, is Astra's argument.
In their latest earnings results statement, the company said:
Prior guidance excluded the revenue and profit impact of sales of the pandemic vaccine. The Company is now expecting to progressively transition the vaccine to modest profitability as new orders are received. COVID-19 vaccine sales in Q4 2021 are expected to be a blend of the original pandemic agreements and new orders, with the large majority coming from pandemic agreements. The limited profit contribution from the vaccine in Q4 2021 is expected to offset costs relating to the Company's long-acting antibody combination (AZD7442), resulting in no change to Core EPS guidance.
The vaccine could actually become an important earner for the company. If you look at the revenue breakup, below, you can see why:
AZN drug performance
AZN
What we see here is that outside of Tagrisso - which has had a bad year due to Chinese hiccups - the vaccine is still, despite all the charity talk, Astra's top earner. Alexion's soliris might top that next year, but the vaccine revenue is going to continue to grow. So the decision to generate that revenue is actually a good decision. The current talks about booster doses are also good for Astra's topline. Recently, it was disclosed that a third dose of AstraZeneca's Vaxzevria increases antibody response against the Omicron variant. The increased response was seen in individuals previously vaccinated with either Vaxzevria or an mRNA vaccine, meaning that the booster dose works even for those who have taken Moderna or Pfizer's vaccines.
AZN is playing a volume game; emerging markets still represent its top earning geography:
AZN PERFORMANCE BY GEOGRAPHY
AZN
"Total Revenue from Emerging Markets increased 33% (28% CER) to $8,618m, of which $1,139m came from the pandemic COVID-19 vaccine. Excluding the COVID-19 vaccine, Total Revenue from Emerging Markets increased by 16% (10% at CER) in the year to date to $7,479m.
In the third quarter of 2021, the Company delivered approximately 67 million doses of its pandemic COVID-19 vaccine through COVAX17. As of 30 September 2021, the Company and its sublicensee Serum Institute of India Pvt. Ltd. (SII) have delivered more than 145 million doses with COVAX to over 125 countries, approximately half of all COVAX supply. The majority of the doses have gone to low and middle-income countries. Globally, AstraZeneca and its sub-licensing partners have released more than 1.5 billion vaccine doses as of the 30 September 2021, for supply in over 170 countries."
These numbers are a big deal. Of the nearly 10 billion vaccines delivered globally, nearly 20% are AstraZeneca's. This is the creation of a large market. If this can be monetized - as the company has begun to do now - I see great future for the company.
