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read about COVID vaccines

J &J vaccine:

 

"The Janssen/J&J vaccine is a single-dose, replication-incompetent human adenovirus type 26 vectored vaccine encoding SARS-CoV-2 spike protein based on the same original Wuhan-Hu-1 strain as other approved vaccines. Short-term storage is at 2-8°C (36-46°F) for up to 3 months, and long-term storage is at 20°C (-4°F) for up to 2 years. In an FDA staff analysis, the primary trial endpoint was efficacy against moderate-to-severe disease (subjects all aged ≥ 18 years), which differs very slightly from the Pfizer-BioNTech COVID-19 Vaccine (Pfizer-BioNTech; also known as Comirnaty or mRNA-BNT162b2) and Moderna COVID-19 Vaccine (Moderna; also known as mRN-1273) trial primary endpoints of any symptomatic disease. Subjects were enrolled from the US, Brazil, and South Africa compared to the US only for Pfizer and Moderna vaccines, and each trial took place at different times in the evolution of the virus and the pandemic. Enrolled subjects analyzed included those who were aged ≥ 60 years (35%), aged ≥ 65 years (20%), black or African American (17%), and 1 or more comorbid conditions (40%). Data (n = 40,000 subjects) from the 3 countries indicates an overall 66.7% efficacy (equal in those aged > 65 years and across races) against all symptomatic (including mild) disease after 28 days (68 and 193 cases in vaccine and placebo groups, respectively) with 72% efficacy in the US (100% standard strain) versus 64% in South Africa (95% B.1.351 strain). Efficacy was lower in those aged ≥ 60 years with comorbid conditions (42%) and in those with HIV infection (48%), but confidence intervals were wide and equivalent data from Pfizer and Moderna vaccines are not clearly comparable. An overall 85.4% efficacy against severe-to-critical disease after day 28 was seen, with 85.9% efficacy in the US and 81.7% in South Africa; efficacy was 92% in those aged 18-59 years, with a fall off to 70% efficacy in participants aged ≥ 60 years. After 28 days, no vaccine recipients developed COVID-19 severe enough to require medical intervention, whereas 7 in the placebo group died and no vaccinated patients died. As a surrogate for the possibility of asymptomatic transmission by vaccinees, Janssen/J&J vaccine showed 74.2% VE against asymptomatic seroconversion to nonspike protein at days 29 through 71 post single dose in subjects with undetected infection (e.g., asymptomatic or no positive PCR test) prior to specimen collection for antibody testing (n = 2,650). No safety signals or anaphylactic reactions were found, and common solicited adverse events such as pain (49%), headache (39%), fatigue (38%), myalgia (33%), and fever (9%) were fewer in older persons; the vaccine does not contain PEG, which was implicated in reactions to mRNA vaccines, but does contain cross reactive polysorbate 80. In summary, a single dose of the Janssen/J&J vaccine is highly effective in preventing hospitalization and death, but it does not appear as effective as mRNA vaccines in preventing severe/critical disease in those aged ≥ 60 years (70% efficacy) or in preventing moderate-to-severe disease in those aged ≥ 60 years with comorbid conditions (42%), though the 3 vaccine trials differ in geography and point of time in the pandemic. Prevention of severe-to-critical disease in healthy persons younger than 60 years (92%) appears equivalent to mRNA vaccines. Enrollment is ongoing for a 30,000-person trial of a 2-dose regimen. Enrollment for immunogenicity and safety studies in children aged 0-17 years will open soon, and studies in pregnant women and immunocompromised persons are planned to begin in late March/early April 2021 and in the third quarter 2021, respectively.

While most jurisdictions are currently in Phase 1b or expanding into Phase 1c, most have made modifications to the ACIP prioritization framework mostly to deprioritize vaccination of essential workers and those with underlying conditions. In part, this is due to continued reliance on large vaccination centers where implementation challenges with adjudicating eligibility of the above mentioned groups during times of constrained supply would greatly hamper throughput.

US authorities remain strongly opposed to delaying the second dose of an mRNA vaccine or using a single dose of an mRNA vaccine for persons previously infected. One dose in an unvaccinated person, even with a lower nAb response, could be protective against the standard SARS-CoV-2 strain but not against novel variants and the duration of immunity after a single dose is unknown. In addition, nAb did not show large increases until after receipt of the 2nd dose (both Pfizer and Moderna). Single-dose boosting of preexisting natural immunity in persons with previous SARS-CoV-2 infection induces robust and likely significant nAb responses, but the correlates of protection are unknown and clinical efficacy data for this approach are not available; many experienced clinicians feel that eventual clinical data will support this approach. Nevertheless, large-scale antibody screening before vaccination is not feasible.

Current bottom-line messaging for vaccination with vaccines currently approved in the US (Pfizer, Moderna, Janssen/J&J) is that: 1) it effectively eliminates the risk of COVID-19 death; 2) it nearly eliminates the risk of hospitalization; 3) it significantly reduces the ability to infect others (preliminary); and 4) full vaccination is highly effective against both B.1.1.7 and B.1.351 variants (preliminary). An efficacy rate of 95% reflects a reduction in infections when vaccinees are compared to an unvaccinated control group of the same size, not what percentage of vaccinees become infected. Relatively few people in a population become infected with COVID-19. In the case of COVID-19, even in heavily affected areas, fewer than 0.1% of vaccinees would expect to become infected, and almost all would have mild disease comparisons between vaccinated and control groups.

New data (preprint) estimates the SARS-CoV-2 positivity rate of a sample of air travelers arriving in Toronto, Canada in September and October of 2020 at arrival, on day 7, and on day 14 by self-administered, oral/nasal PCR swab. Of 16,361 passengers voluntarily enrolled, 1.5% (248) tested positive at some point. Of those that tested positive, 67% were identified on arrival, 27% on day 7, and 6% on day 14. Thus, a single arrival test will pick up two-thirds of individuals who will become positive, and 94% will be positive on the second test at day 7, providing evidence for a reduced quarantine period. The arrival testing results indicate that up to 1% of all passengers on long-haul international flights are possibly infectious in the origin/arrival airport or inflight. The study did not assess secondary transmission inflight and some nonparticipation bias is possible.

Increasing evidence from a large number of studies indicates both adequate neutralization by sera from vaccinated persons as well as high clinical efficacy in vaccinated populations in areas where either the B.1.1.7 or B.1.351 variant is widely circulating; data for Pfizer, Moderna, and Janssen/J&J vaccines are available in this regard. Concern over immune escape by variants appears to be diminishing. As of March 1, 2021, at least 2,300 persons infected with the B.1.351 variant have been identified in over 50 countries. The US has now detected 53 cases of B.1.351 in 16 states. In the US, as of February 28, 2021, the B.1.1.7 variant accounts for 10% of all isolates, up from an estimate of 1% to 4% 16 days ago, and has been reported in 2,400 persons in 46 states, mainly Florida (599) and Michigan (421). According to Israel's Health Ministry, a total of 3 confirmed reinfections with the B.1.351 variant have occurred in persons recovered from earlier infection with standard strains of SARS-CoV-2, confirming earlier findings from South Africa that infection with standard strains does not confer protection to reinfection with B.1.351.

In the US, the 7-day rolling average of daily vaccinations is 1.38 million doses (range 500,800–1.77 million) with continued reliance on large vaccination centers where adjudicating eligibility (e.g., essential workers and those with underlying medical conditions) is difficult. First-dose vaccine coverage ranges from 11.1% to 22.8% across different states; most jurisdictions are in Phase 1b or expanding into Phase 1c, though most states are selectively mixing priority levels. As of March 1, approximately 80% of the doses distributed to states have been administered; more than 50.73 million (M) people have received at least 1 dose of vaccine, and 25.47M have received 2 doses. Globally, approximately 246M COVID-19 vaccination doses have been administered since December 2, 2020, in 110 countries, including all 27 countries in the EU. The number of doses/percentage of the population vaccinated for the top 10 countries are as follows: US (> 76.9M/23.43% as of March 1), China (> 40.52M/2.82% as of February 9), UK (> 20.89M/30.77% as of February 27), India (14.3M/0.95% as of February 28), Turkey (8.55M/10.14% as of February 28), Brazil (> 8.43M/3.97% as of February 28), Israel (> 8.09M/93.5% as of February 28), Germany (> 6.17M/7.37% as of February 28), UAE (> 6.02M/60.87% as of February 28), France (> 4.55M/6.71% as of February 27). The data for percentage of the population vaccinated are imperfect because distinguishing between first doses and second doses is not always possible.

In Canada, COVID-19 Vaccine AstraZeneca (AstraZeneca; adenovirus; also known as AZD1222 and as Covishield in India) has been approved for use in persons aged ≥ 18 years (including those aged ≥ 65 years). Twenty-two million doses have been purchased with most arriving in the second and third quarters of 2021; they will pose fewer logistical challenges for distribution than the Pfizer and Moderna vaccines for which Canada has secured nearly 100 million doses.

Very preliminary, non-peer reviewed data on an increasing number of "scariants," especially those containing the already known E484K variants, continue to appear in the media and from politicians. Mutations will continue to appear slowly in SARS-CoV-2, and the effect of each one requires detailed study of virulence, transmissibility, and immune escape potential. WHO has now published defining criteria to differentiate Variants of Interest (VOI) from Variants of Concern (VOC). VOC cannot readily be determined on a theoretical basis, and peer-reviewed population-based data are required for validation by WHO of a VOC. At present, the significance of either the "New York variant" or the "California variant" is unknown. Variants should be presumed innocent until proven guilty by WHO.

Pfizer and Moderna have both launched 3 lines of study to deal with the B.1.351 variant: a variant-specific monovalent booster candidate based on the B.1.351 variant, a multivalent booster candidate which combines the current authorized vaccine against ancestral strains with a B.1.351 variant in a single vaccine, and a third dose of the current vaccine at 6 to 12 months for those who have already completed the primary series. Current antibody titer data indicate that the 2 current mRNA vaccines do stimulate immunity against the B.1.351 variant, but at lower levels than against ancestral strains after 2 doses of existing vaccine. Both Pfizer and Moderna note that they have yet to see compelling evidence that variants are resistant to their vaccines, although they are taking steps to be prepared.

Delta Airlines, the largest US air carrier, has stated that domestic travel remains the focus for the remainder of 2021. Delta is forecasting that resumption of international travel in any meaningful form will not start until spring of 2022, blaming the lack of testing and vaccine distribution across the world. IATA has stated that globally, forward bookings for summer are currently 78% below levels in February 2019.

CDC technical specifications for conducting test cruises, an integral part of a conditional sail order, are expected any day. The test cruises are designed to show that a line is successful in mitigating the risk of SARS-CoV-2 spreading to crew, passengers, and communities; an additional 30 to 60 days would be required for a sail order to be issued.

In the US, daily new cases (7-day average) have plateaued since February 14 at approximately 69,000 per day after a dramatic drop from approximately 250,000 on January 8; this plateau is identical to the peak levels in late July 2020 that formed the summer surge. In Europe, daily new cases (7-day average) have plateaued since February 24, 2021, at approximately 136,400 per day following a steady decrease after January 12 to a nadir of 127,200 on February 18. Two peaks of 287,000 and 252,000 occurred on November 8, 2020, and January 11, 2021, respectively. Weekly new cases have increased in 32 European counties including France, Germany, and Italy, and have decreased in 14 countries including Russia, Spain, and the UK.

Israel continues to have the largest dataset of real-world experience with the Pfizer vaccine; formal publication of it is now available in the New England Journal of Medicine. A vaccinated and a matched non-vaccinated control group each included 596,618 persons. Estimated vaccine effectiveness at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% and 92%; for symptomatic Covid-19, 57% and 94%; for hospitalization, 74% and 87%; and for severe disease, 62% and 92%, respectively. Efficacy of 92% matches that of the Phase 3 trials. Estimated effectiveness in preventing death from Covid-19 was already 72% for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups including those aged > 65 years, with potentially slightly lower effectiveness in persons with multiple coexisting conditions. Of note, the B.1.1.7 variant strain predominates in Israel.

The US NIH has begun to fund research into the long-COVID-19 syndrome now technically designated as postacute sequelae of SARS-CoV-2 infection, or PASC. One new study has shown persistent symptoms (mostly fatigue and loss of smell) in up to one-third of those who had mild initial infection, and symptoms which lasted for a median of 6 months and as long as 9 months after acute infection.

Similar to the IDSA approach for monoclonal antibody therapy, the US NIH guidelines now recommend for the use of bamlanivimab (LY-CoV555; EUA; Eli Lilly) plus etesevimab (LY-CoV016; EUA; Eli Lilly) for the treatment of outpatients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease. Treatment may also be considered in persons with mild-to-moderate COVID-19 with risk of progression who are hospitalized for a reason other than COVID-19. Treatment should be started as soon as possible after a positive diagnostic test result and within 10 days of symptom onset. Use of this monoclonal antibody cocktail is not recommended for hospitalized COVID-19 patients except in a clinical trial. The US has purchased more than 100,000 doses of this dual antibody cocktail to be delivered through the end of March with an option to purchase up to an additional 1.1 million doses through November 2021.

IDSA now recommends the use of tocilizumab (Actemra; Roche) in addition to standard of care (e.g., dexamethasone) in hospitalized COVID-19 patients with progressive severe or critical disease who have elevated markers of systemic inflammation (e.g., elevated C-reactive protein) rather than standard care alone. Tocilizumab demonstrated a statistically significant reduction of 28-day mortality compared to no tocilizumab treatment and a lower relative risk of clinical deterioration (e.g., need for mechanical ventilation, ECMO, ICU admission, or death) compared to placebo/standard care.

Weekly production of the US supply of the Pfizer vaccine is expected to double by early March due to expansion of its production network and improvements in the manufacturing and quality control process which will reduce the production time from 110 days to 60 days. Pfizer plans to increase distribution to 13 million doses per week (up from 5 million) by mid-March and expects to ship 120 million doses by the end of March and 200 million doses by the end of May. Distribution of the Moderna vaccine is expected to double by April to more than 40 million doses per month, with delivery of 100 million doses expected by the end of March and an additional 100 million doses by the end of July. Distribution of the available 4 million doses of the newly authorized Janssen/J&J vaccine is underway and will be completed by March 6; delivery of a total of 20 million doses is likely by the end of March, with a total of 100 million doses by the end of June. Allocation of supply of each of the 3 vaccines to each state, tribe, or territory is independent of the other authorized vaccines and is proportional to the population of the jurisdiction.

For additional information, see the sortable table Cases by Country (updated by 7:00 p.m. ET every Monday, Wednesday, and Friday and reflected on individual Destination pages), a U.S. map (updated by 5:00 p.m. ET Monday and Thursday), and a world map (updated by 5:00 p.m. ET Tuesdays).

Travel Restrictions are found on individual Destination pages (key countries updated daily; all others Tuesday and Friday). The Weekly Epidemiologic Summary section of the Outbreak Report is updated by 7:00 p.m. ET every Wednesday and included in the News Alert email.

                                       This material is obtained from the internet for the Jordanian  medical community​