Category: Corona Virus Vaccine

The largest global vaccine safety study has linked COVID-19 vaccines with small increases in health conditions involving the brain, blood, and heart.

The international team of researchers emphasizes that the chances of getting any of these conditions are still very low. It's important to note that extensive research shows COVID-19 vaccines protect against serious illness, death, and long COVID symptoms.

Across just under 100 million COVID-19-vaccinated people in eight countries, potential links called safety signals were identified by comparing observed rates of 13 specific conditions following vaccination to what we'd expect to see based on prior rates, or 'background risk' of the conditions the rates that these conditions are expected to occur in the absence of COVID-19 vaccines.

"The risk up to 42 days after vaccination was generally similar to the background risk for the majority of outcomes," the authors write in their published paper.

The authors say their multi-country analysis confirmed pre-established links between COVID-19 vaccinations and low risks of myocarditis, pericarditis, Guillain-Barr syndrome, and cerebral venous sinus thrombosis. But the enormous size of the study also meant there was a higher chance of them spotting rarer safety signals that prior studies may have missed.

Since the World Health Organization declared the COVID-19 pandemic on March 11, 2020, nearly 7 million people have died from the disease, including more than 1 million in the US. Over 13.5 billion doses of COVID-19 vaccines have been given, with at least 70.6 percent of the world's population having received at least one dose.

Vaccine rollouts usually identify common and moderate side effects, after excluding dangerous ones during clinical trials. But even in huge clinical trials, extremely rare side effects can go undetected.

"This unparalleled scenario underscores the pressing need for comprehensive vaccine safety monitoring, as very rare adverse events associated with COVID-19 vaccines may only come to light after administration to millions of individuals," the authors write.

Their study sought safety signals observed within the 42 days after receiving viral-vector vaccines (such as AstraZeneca) or mRNA vaccines (such as Pfizer-BioNTech). Health datasets from before the COVID-19 vaccines were used to determine the rates of these conditions that were expected in the general population prior to vaccine rollout, and the observed rates were derived from the same dataset after vaccination.

In the wake of viral-vector vaccines, the team discovered a statistically significant rise in cases of Guillain-Barre syndrome; a rare immune system disorder that affects nerves. Within the group that had these vaccines, 66 cases were expected, and 190 were observed. This increase was not seen after mRNA vaccines.

Following a first dose of the AstraZeneca vaccine, there was a 3.2 times greater-than-expected risk of cerebral venous sinus thrombosis (a type of blood clot in the brain) observed in 69 events, compared to an expected 21. The risks were 1.49 times higher after the Pfizer vaccine's first dose, and 1.25 times higher after second doses.

In March 2021, some countries in Europe suspended the AstraZeneca COVID-19 vaccine after observed versus expected analysis identified thrombosis with thrombocytopenia syndrome as a safety signal.

The analysis found a higher risk of heart inflammation called myocarditis after mRNA vaccines, with observed rates highest after a second dose of Moderna's vaccine. These vaccines instruct cells to produce a protein that resembles the SARS-CoV-2 virus, giving the immune system a preview and prompting it to create antibodies to protect the body.

In rare cases, this immune response can result in heart muscle inflammation. Though COVID-19 vaccine-induced instances have mostly been mild, 28 deaths have occurred.

After a first dose of mRNA vaccines, the risk for pericarditis inflammation of tissue surrounding the heart was 1.7 times higher than expected, and it became 2.6 times higher after a fourth dose.

Potential safety signals were found for transverse myelitis (inflammation of part of the spinal cord) after viral-vector vaccines, and for acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after both types of vaccines.

Compared to an expected two cases, seven cases of acute disseminated encephalomyelitis were observed after mRNA vaccines.

"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," says first author Kristna Faksov, an epidemiologist at the Department of Epidemiology Research in Denmark.

"Single sites or regions are unlikely to have a large enough population to detect very rare signals."

Vaccines have saved countless lives by preventing the spread of the COVID-19 pandemic, and there is strong evidence that they are safe in the majority of cases and effective. A recent study found that if everyone in the UK was fully vaccinated, about 7,180 out of 40,393 severe outcomes (including deaths) from COVID-19 could have been avoided.

"We have a number of studies underway to build upon our understanding of vaccines and how we understand vaccine safety using big data," says Steven Black, an infectious disease scientist at the Global Vaccine Data Network (GVDN).

Anyone can view the methodology and complete results of this analysis on the GVDN's interactive data dashboards.

The study has been published in the journal Vaccine.

Read more:

Largest COVID Vaccine Study Ever Reveals The Actual Health Risks You Face - ScienceAlert

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An 8 percent vaccination rate, Long COVID, free treatment options explained by healthcare professionals - The News Leader

Demographics of and reported breakthrough infections in the study population

This study continued the follow-up of humoral antibody responses of healthcare workers (HCWs) who received two BNT162b2 vaccine doses with short three-week interval (n=230, short group) or two doses of BNT162b2, mRNA-1273, or ChAdOx1 plus BNT162b2/ mRNA-1273 with a long 12-week (n=202, long group) interval before the third vaccine dose. We have previously analyzed this cohort up to 3 months after the third vaccine dose7,8,10. The novel data obtained in this study is the analysis and follow-up of serum samples up to 9 months after the 3rd vaccine dose. In Finland, COVID-19 vaccinations were first carried out with a short three-week interval, and later in the spring of 2021 the interval was lengthened to 12 weeks. Thus, the vaccinees in the short interval group received their third dose before those in the long interval group. Our analysis included serum samples collected before the first vaccination and before the third vaccination up to nine months after the third vaccine dose (short and long interval groups) (Figs.1a and 2a). The age range of the participants at the time of the first vaccine dose ranged from 20 to 65 years (mean 42.7 and median 41.2 years) in the short interval group and 2267 years (mean 45.7 and median 46.3 years) in the long interval group (Table1). Eighty-nine percent of the study participants were females.

Six of the vaccinees in the short interval group and fifteen in the long interval group had had a SARS-CoV-2 infection (confirmed by PCR) before the first vaccination. The number of PCR/antigen test-confirmed SARS-CoV-2 infections increased in the study population (and in Finland) after the emergence of the Omicron variants. The majority of the vaccinees had received their third dose by the end of 2021, and thus, the breakthrough infections occurred mostly after the third vaccine dose: HCWs in the short interval group reported 98 infections after the third dose and HCWs in the long interval group reported 10 infections after two doses and 80 after three vaccine doses (Table1).

To estimate the changes in humoral immunity after vaccination with three doses of COVID-19 mRNA vaccines and potential exposure to circulating SARS-CoV-2 variants, we analyzed the changes in SARS-CoV-2 spike protein subunit 1 (S1) and nucleoprotein (N) specific IgG antibody levels in the sera of HCWs in the short interval group (Fig.1, the timeline of the vaccinations, serum collections and circulating variants is shown in Fig.1a). The third vaccination induced strong S1-specific IgG responses, which peaked at 3 weeks post the vaccination and decreased thereafter (Geometric mean of antibody levels 128.9 EIA units at 3D3wk, 99.96 EIA units at 3D3mo, 93.19 EIA units at 3D6mo, and 99.73 EIA units at 3D9mo; Fig.1b). The reported (PCR or antigen test confirmed) or serologically observable (increase in S1-specific or N-specific antibodies greater than the cut-off, 4.8 or 8.8 EIA units, respectively) SARS-CoV-2 infections increased the S1-specific and N-specific antibody levels (Fig.1b, e). Follow-up of the vaccinees showed that the majority of infected vaccinees had an increase in anti-S1 and anti-N antibodies after the time period of a reported infection (red lines in Fig.1c, f).

Five vaccinees in the short interval group had SARS-CoV-2 N-specific antibodies prior to vaccination8 (Fig.1e): Two of these had had a PCR test confirmed SARS-CoV-2 infection before the vaccination while the other three had elevated but stable anti-N antibody levels without a sign of antibody decline. Grouping of the vaccinees based on their infection status (Fig.1d, g) showed that the anti-S1 and anti-N levels were significantly different between HCWs with or without a breakthrough infection at 6 months after the third vaccine dose (non-infected 72 EIA units vs. infected 112 EIA units for S1, p<0.0001 and 1.4 EIA units vs. 22 EIA units for N, p<0.0001) after the time point of three months after the third vaccine dose. In some vaccinees, the infection-induced antibody response was delayed and, therefore, was detectable only in the later time points, while 13 infected vaccinees showed no or little changes in S1-/or N-specific antibodies (Fig.1c, f).

HCWs with a long vaccine interval received two doses of BNT162b2, mRNA-1273, or a combination of ChAdOx1 and BNT162b2/mRNA-1273 as the first two doses (Table1). Sequential serum samples were collected before the vaccination and at regular intervals after each vaccine dose and analyzed for S1- and N-specific IgG antibody levels (Fig.2, the timeline of the vaccinations, serum collections and circulating variants is shown in Fig.2a). The first vaccine dose induced a wide range of S1-specific antibody levels, and substantially higher levels in previously infected HCWs (Fig.2b, c, black dots). While the second and the third doses increased S1-specific antibody levels higher, follow-up of the antibody levels of each vaccinee showed increases also before the third dose and after the first time point post the third vaccine dose (Fig.2c). A vast majority of these increases coincided with a reported SARS-CoV-2 infection (PCR test or antigen test confirmed) preceding the sampling and most of these HCWs also had an increase in N-specific antibodies at the same time (Fig.2e, f).

A separate analysis of antibody responses in individuals that had or had not contracted an infection (PCR or antigen test confirmed, or serologically observable) showed a decrease (Geometric mean 115.4 EIA units at 3D3wk vs 32.94 EIA units at 3D9mo) in anti-S1 antibody levels prior to the next vaccine dose in case there was no infection (p<0.0001; Fig.2d). A SARS-CoV-2 breakthrough infection increased the S1-specific antibody levels when responses of infected and uninfected were compared three and six months, respectively, after the third dose (Geometric mean 82.30 EIA units at 3D3mo vs 130.6 EIA units at 3D3mo infected, 55.02 EIA units at 3D6mo vs 130.6 EIA units at 3D6mo infected) p<0.0001; Fig.2d). Also, the N-specific antibody levels were induced by an infection, although the N-specific response was absent or low in 25 of the infected vaccinees (Fig.2eg). A decline in N-specific antibodies was observed in the sequential samples from participants infected pre-vaccination or post-vaccination while a few vaccinees had relatively high basal N-antibody levels without an indication of a decline in antibody (blue dots above cutoff value, Fig.2f).

Of the 412 HCWs who had serum samples available after the third COVID-19 vaccine dose, 44% (182/412) reported a positive COVID-19 test (PCR or antigen) post third vaccine dose. Furthermore, 95% (173/182) of the COVID-19 test-positive HCWs showed a serological indication of infection, defined as a diagnostic increase in either S1- or N-specific antibodies (increase greater than cut-off, 4.8 EIA units for S1 after the time point of 3D3wk, and 8.8 EIA units for N after the third dose; Table2). Of the COVID-19 test negative (or untested) HCWs, 13% (30/246) had a serological indication of infection by S1- or N-specific antibody levels, making the proportion of HCWs with a breakthrough infection, confirmed either by COVID-19 test or serology, after three vaccine doses 51% (212/412). Of note, measuring only S1 or N-specific antibodies was less sensitive at detecting infected individuals, since only 64% (117/182) of the COVID-19 test-positive HCWs had an increase in both anti-S1 and anti-N antibodies. Thus, serological detection of past infection was most accurate when IgG antibodies for both S1 and N antigens were positive.

We also examined the antibody levels of HCWs and compared those to their COVID-19 test and serological status. We found that infection soon after a COVID-19 vaccination was more likely to lead into lack of serological indication of infection. Seventeen per cent (10/60) of the HCWs who had a short interval between the third COVID-19 vaccine dose and a positive COVID-19 test (vaccination less than three months before a positive COVID-19 test, Supplementary Fig.1) had no serological indication of an infection. Only 5% of the HCWs with a longer vaccine interval between COVID-19 vaccination and infection lacked serological indication of an infection (vaccination three to six months before a positive COVID-19 test, Supplementary Fig.2).

To determine the comparative efficiency of BNT162b2 and mRNA-1273 as the third dose, S1-specific antibody responses were analyzed after the third vaccine dose in uninfected HCWs. In both short and long-interval groups, the vaccine-induced antibody responses had similar kinetics, with the S1 antibody level peaking at 3 weeks after vaccination, followed on an average by a 25 EIA unit decline in subsequent samples (Fig.3a, b). The mRNA-1273 vaccine as the third dose provided significantly higher S1-specific antibody responses in both interval groups (p<0.0423 in the short interval group and p<0.0300 in the long interval group). The difference between the groups receiving BNT162b2 or mRNA-1273 as the third dose in the long interval group was observable already prior to the third dose (a result of different vaccine combinations before the third dose, different vaccine combination groups marked with different colors in Fig.3b), and the difference in antibody levels remained observable also after the third dose (Fig.3b).

SARS-CoV-2 S1-specific IgG antibody responses induced by Bnt162b2 or mRNA-1273 (triangles) as the third vaccine dose were compared in the sera of uninfected vaccinees who received a two doses of Bnt162b2 with a short, three-week dose interval or b two doses of Bnt162b2 (orange), mRNA-1273 (violet), or ChAdOx1 + Bnt162b2/mRNA-1273 (green) with a long dose interval before the third vaccine dose. SARS-CoV-2 S1-specific IgG antibody responses were analyzed by EIA in serum samples collected before the third dose (2D6mo or 2D8mo) and after the third vaccine dose (3D3wk, 3D3mo, 3D6mo, and 3D9mo). Geometric means geometric standard deviations of antibody levels, and number of samples in each time point are shown. Dashed lines indicate the cut-off values for seropositivity.

Our study included HCWs aged 19 to 67 years at the time of the first vaccine dose. To examine whether age affects humoral immune responses induced by COVID-19 vaccines, we analyzed anti-S1 IgG antibody levels in relation to age from uninfected HCWs (Supplementary Fig.3). Some decrease in antibody levels was observed by increasing age, but a higher age did not prevent the induction of high antibody levels. Although the oldest age group, 5567-year-olds, had, on average, the lowest antibody levels at 3 and 6 months after the third vaccine dose the antibody levels were relatively equal between all age groups (Supplementary Fig.4).

Neutralizing capacity of the sera against SARS-CoV-2 variants was first examined in the short interval group by randomly selecting a subset of 41 HCWs (no prior PCR-confirmed SARS-CoV-2 infection). MNT was used to analyze in vitro neutralizing antibody titers against the ancestral D614G variant and the five recent SARS-CoV-2 Omicron variants, BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 in serum samples collected at six months after the second vaccine dose (2D) and 3 weeks (3wk), three months (3mo), and six months (6mo) after the third booster dose (3D). (Fig.4al).

HCWs received two doses of BNT162b2 with a three-week interval and a third dose of BNT162b2 (circle) or mRNA-1273 (triangle) eight months later. af Serum samples were collected 6 months after the second vaccine dose (2D6mo, n=41), 3 weeks (3D3wk, n=40), 3 months (3D3mo, n=41), and 6 months (3D6mo, n=39) after the third dose and analyzed with MNT for neutralizing antibodies against SARS-CoV-2 D614G and Omicron BA.1, BA.2, BA.5, BQ.1.1 (BA.5 subvariant), and XBB.1.5 (BA.2 subvariant) variants. HCWs with confirmed SARS-CoV-2 infection between three and six months after third dose (n=12) were separated (red dots and triangles; infected 3D6mo). Half-maximal inhibitory dilutions (ID50) were calculated, and titers <10 were marked as 5. Geometric mean titers for vaccine groups are indicated above each time point and shown as lines with geometric SDs. gl Sequential serum samples of each individual are connected with lines. Red lines indicate where a vaccinee has had a PCR or antigen test confirmed SARS-CoV-2 infection. mq Top and side views of trimeric SARS-CoV-2 spike protein structure (PDB: 7WK2) show amino acid differences of Omicron BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 compared to Wuhan Hu-1 sequence as amino-acid substitutions (orange) and deletions (red).

Six months after the second vaccine dose, 95% of the vaccinees (39/41) neutralized the D614G and 44% (18/41), 76% (31/41), 90% (37/41), 5% (2/41), and 0% (0/41) neutralized Omicron BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 variants, respectively (Fig.4af). The third vaccine dose increased neutralizing antibodies against all variants, although the levels against BQ.1.1 and XBB.1.5 variants remained lowest. Despite the gradual decrease in the levels of neutralizing antibodies after the third dose, the geometric mean titers (GMT) were 4.47.2x higher six months after the third dose in comparison to 6 months after the second dose, (80 vs 364 for D614G, 9 vs 47 for Omicron BA.1, 24v. 173 for BA.2, and 26 vs 125 for BA.5; p<0.0001 for each pair). For Omicron BQ.1.1 and XBB.1.5 variants, the GMTs were 2.0x and 2.4x higher (5 vs. 12 for Omicron BQ.1.1, p=0.0003, and 5 vs. 10 for Omicron XBB.1.5; p=0.0001). Six months after the third dose only two samples had titers below the detection limit for Omicron BA.1, one sample for BA.2, 12 samples for BQ.1.1 and 17 samples for XBB.1.5. The results suggest that the neutralization efficiency of the induced antibodies is still reasonably high against the earlier Omicron variants, but is strongly reduced against BQ.1.1 and XBB.1.5 variants, with the number of samples below the detection limit increasing at the 3D6mo time point.

Twelve of the 41 vaccinees reported a PCR-confirmed SARS-CoV-2 breakthrough infection between the sampling of three and six months after the third dose. The breakthrough infection increased the levels of neutralizing antibodies, and the GMTs were 625x higher compared to non-infected participants (364 in non-infected vs. 2239 in infected at 3D6mo for D614G, 47 vs. 644 for Omicron BA.1, 173 vs. 997 for BA.2, and 125 vs. 910 for BA.5, 5 vs.126 for BQ.1.1, and 5 vs. 109 for XBB.1.5; p=0.0002 for D614G and Omicron BA.2, p<0.0001 for Omicron BA.1 and BA.5, and p

To study differences in neutralizing antibody titers elicited by different vaccine combinations and vaccine dose intervals against D614G and Omicron BA.1. BA.2, BA.5, BQ.1.1, and XBB.1.5 sera from a representative number of HCWs (with two BNT162b2 with a short (n=41) or with a long vaccine dose interval (n=35), two mRNA-1273 (n=31), or ChAdOx1 and BNT162b2 or mRNA-1273 (n=45) before the third dose of BNT162b2 or mRNA-1273) were analyzed with MNT (Fig.5). At 6 months after the second vaccine dose, the majority of vaccinees in each vaccine combination group had neutralizing antibodies against D614G variant and Omicron BA.2 and BA.5, whereas all vaccine combination groups had lower or undetectable levels of neutralizing antibodies against Omicron BA.1, BQ.1.1, and XBB.1.5. Interestingly, 2 x mRNA-1273 induced higher neutralizing antibody titers at 2D6mo against all variants, before the administration of the third vaccine dose. The third vaccine dose increased neutralizing antibody titers in all vaccine groups resulting in neutralizing antibody titers above the detection limit against all Omicron variants, leaving only four vaccinees below the detection limit against BQ.1.1 and ten against XBB.1.5. Interestingly, in Omicron variants 3 weeks after the third dose, the short interval 2 x BNT162b2 vaccine group had the highest GMT, even 1.11.9x higher than in the 2 x mRNA-1273 group (Fig.5).

Serum samples, collected 6 months after the second dose (2D6mo), 3 weeks (3D3wk), and 3 months (3D3mo) after the third vaccine dose from HCWs who received 2x BNT162b2 with a short vaccine dose interval (n=41, yellow circles and triangles) or 2x BNT162b2 (n=35, orange circles and triangles), 2x mRNA-1273 (n=31, purple circles and triangles), or ChAdOx1+BNT162b2/mRNA-1273 (n=45, green circles and triangles) with a long vaccine dose interval, and a third dose of BNT162b2 (circle) or mRNA-1273 (triangle) were compared for neutralizing antibody responses against D614G and Omicron variants BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5. HCWs with confirmed SARS-CoV-2 infection between the samplings at 3 weeks and three months after the third dose (3D3wk and 3D3mo) were separated (3 doses + infection, n=24, red circles and triangles). Half-maximal inhibitory dilutions (ID50) were calculated, and titers <10 were marked as 5. Geometric mean titers (GMTs) for each vaccine group are shown as lines with geometric SDs.

Three months after the third vaccine dose, the decrease in neutralizing antibody titers against D614G, and the Omicron variants was similar in all vaccine combination groups, and the neutralizing titers remained slightly higher in the 2 x BNT162b2 and 2 x mRNA-1273 vaccine groups than in the other groups. The difference in neutralization of Omicron BA.1 and XBB.1.5 was significant when the titers in short 2 x BNT162b2 group were compared to titers in ChAsOx1+BNT162b2/mRNA-1273 group (GMT 40 vs. 99 against BA.1, p=0.0014; GMT 8 vs. 16 against XBB.1.5, p=0.0024) and 2x mRNA-1273 group (GMT 8 vs. 16 against XBB.1.5, p=0.040).

Between the sampling of 3 weeks and three months after the third dose, 24 of the HCWs with the long vaccine interval reported a COVID-19 test-positive SARS-CoV-2 breakthrough infection (red dots in Fig.5). The neutralizing antibody titers against the four variants were significantly higher in infected than in non-infected HCWs. Only one HCW with three vaccine doses and an infection had neutralizing antibody titers against Omicron XBB.1.5 below the detection limit. Altogether, these results indicate that the studied vaccine combinations elicit high titers of SARS-CoV-2 neutralizing antibodies against Omicron BA.1, BA.2, and BA.5 variants, while the titers against the Omicron BQ.1.1 and XBB.1.5 were yet relatively low. An infection within three months after three vaccine doses elicits high neutralizing antibody titers against all Omicron variants.

The estimation of neutralization capacity of COVID-19-vaccinated individuals against different variants is central in deciding the need for further vaccine doses. Here, we compared the neutralizing antibody titers of HCWs without breakthrough infection against D614G and Omicron variants BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 in the order these variants emerged (Fig.6). Regardless of the vaccine combination, the neutralizing capacity of the antibodies was 4.811.5x reduced 3 weeks and 3 months after the third vaccine dose when moving from D614G variant to Omicron BA.1, 2.14.6x increased from Omicron BA.1 to BA.2, and again1.52.3x reduced from Omicron BA.2 to BA.5, and 4.99.9x further reduced to BQ.1.1 and to XBB.1.5. The only exception was the 2 x mRNA-1273+BNT162b2/mRNA-1273 group, as in this group there was no significant difference between the neutralization capacity against Omicron BA.2 and Omicron BA.5 (GMT 503 vs 359) at 3 weeks after the third dose.

Comparison of neutralizing antibody titers against D614G and Omicron variants BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 at 3 weeks (3D3wk) and three months (3D3mo) after the third vaccine dose of HCWs without SARS-CoV-2 infection within each vaccine combination group (2x BNT162b2 with a short, n=40 at 3D3wk and at 3D3mo or a long vaccine dose interval, n=34 at 3D3wk and n=27 at 3D3mo; 2x mRNA-1273 n=31 at 3D3wk and n=24 at 3D3mo; or ChAdOx1+BNT162b2/mRNA-1273, n=44 at 3D3wk and n=35 at 3D3mo). Half-maximal inhibitory dilutions (ID50) were calculated, and titers <10 were marked as 5. Geometric mean titers (GMTs) for each vaccine group are indicated above bars and shown as lines with geometric SDs.

The follow-up of neutralizing antibodies in HCWs who had a breakthrough infection showed that the infection boosted the titers of neutralizing antibodies 1.77.9x against the tested variants (Fig.7). The fold difference between the Omicron variants was relatively similar at all time points (1.52.1x between BA.1 and BA.2, 1.41.5 between BA.2 and BA.5 etc.), while saturation of titers for D614G affected the measured GMT values (Supplementary Fig.5). The comparable fold difference between the variants in both pre-infection and post-infection samples from vaccinees suggests that an Omicron variant infection equally enhances the existing neutralizing antibody response against various variants.

Neutralizing antibodies against D614G and Omicron variants BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 of a 12 HCWs with short vaccination interval and b 23 HCWs with long vaccination interval with a breakthrough infection were compared. Half-maximal inhibitory dilutions (ID50) were calculated before third COVID-19 vaccine dose (2D6mo), and 3 weeks (3D3wk), 3 months (3D3mo), and 6 months (3D6mo, only for short vaccine interval group) after receiving the third COVID-19 vaccine dose. Uninfected individuals are marked with blue (long interval) or yellow (short interval) diamonds, infected individuals with red diamonds. Titers <10 were marked as 5. Titers of each vaccinee in different time points are connected with lines. Red line indicates the period of a PCR- or serology-confirmed infection. Geometric mean antibody titers with standard deviations are shown as bars and lines at each time point.

To analyze the correlation of the antibody responses induced by the vaccinations against the Omicron variants BA.1, BA.2, BA.5, BQ.1.1, and XBB.1.5 and the ancestral D614G variant, the neutralization efficiency of 499 serum samples from 155 vaccinees was pairwise compared between the six SARS-CoV-2 variants (Supplementary Fig.6). Neutralizing antibody titers against the D614G variant were higher than against any of the Omicron variants. Even though the neutralization efficiency between different variants varied, they correlated well with each other (r=0.77710.8766, p<0.0001 for all pairwise comparisons).

Parallel examination of neutralizing antibody titers (for BA.5 as an example) and IgG responses for S1 and N showed similar kinetics following the third vaccine dose and breakthrough infections in both short and long vaccine interval groups (Supplementary Fig.7). In the long vaccine interval group the breakthrough infections (n=23) occurred closer to the third vaccine dose (between 3D3wk and 3D3mo) than in the short vaccine interval group (n=12, between 3D3mo and 3D6mo). Of the 12 short vaccine group HCWs with a confirmed breakthrough infection 92% (11/12) had an increase in anti-N and 83% (10/12) in anti-S1 antibodies, and 83% (10/12) had at least a 4x-increase in Omicron BA.5-specific neutralizing titers. In the long-interval vaccine group serological evidence for a breakthrough infection was detectable in anti-N antibodies in 65% (15/23), in anti-S1 antibodies in 78% (18/23), and for Omicron BA.5 neutralizing titers in 48% (11/23) of infected HCWs. Three HCWs with a COVID-19 test-positive infection showed no increase in S1- or N-specific IgG antibodies, however, two of these had their serum sampling close (810 days) to the positive COVID-19 test date, and this may have been too early after the infection to detect newly formed antibodies.

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Neutralizing antibodies after the third COVID-19 vaccination in healthcare workers with or without breakthrough ... - Nature.com

COVID-19 vaccine does not impact donor eligibility

The American Red Cross wants to remind the public that receiving a COVID-19 vaccine does not make you ineligible to donate blood and blood donations from those who have been vaccinated for COVID-19 are safe for transfusion.

The Red Cross, like all blood collectors in the U.S., is required to follow the eligibility guidelines set by the Food and Drug Administration (FDA), including guidance regarding blood donor eligibility related to those who receive vaccinations, such as a COVID-19 vaccine and others.

The FDA permits individuals to donate blood with no wait period after receiving a COVID-19 vaccine as long as they are feeling well and symptom free, and the vaccine they received is one approved by the FDA for use in the US. Those who report they have received a COVID-19 vaccine are asked to provide the name of the manufacturer to ensure it is an FDA approved vaccine. If the donor cannot remember the name of the manufacturer, they are asked to wait two weeks from their vaccination to give blood.

RapidPass helps donors save time

To help donors save time at their next donation, the Red Cross offers a RapidPass, where donors can complete their pre-donation reading and health history questionnaire online, on the day of their donation, before arriving to the blood drive.

Its important to note the RapidPass is not able to determine blood donation eligibility, so our phone number, 1-800-RED CROSS, is listed alongside many of the questions to allow donors to get additional eligibility information prior to making a trip to donate. For example, this note displays on the question about if you have received a COVID-19 vaccine because those who indicate that they have received a COVID-19 vaccine are then asked to provide the name of the manufacturer to ensure it is an FDA-approved vaccine. Those who have received an FDA approved COVID-19 vaccine may be able to donate as long as they feel well and meet all other donor eligibility criteria.

A Safe Blood Supply

Blood donations from those who have been vaccinated for COVID-19 are safe for transfusion. Similar to other vaccines such as measles, mumps or influenza, the COVID-19 vaccine is designed to generate an immune response to help protect an individual from illness, but vaccine components themselves are not found within the bloodstream.Additionally,a donors immune response is not impacted by giving blood. Donating blood after receiving a COVID-19 vaccine does not reduce a donors protection from the virus.

More information about blood donation safety: Joint Statement: Blood Community Reiterates the Safety of Americas Blood Supply for Patients (redcross.org).

More about vaccines

For some vaccinations, the FDA requires varying wait times to donate blood depending on the vaccine. This includes wait times that can vary from 2 to 4 weeks for a number of vaccines including but not limited to measles, mumps and rubella, chicken pox, shingles, polio, yellow fever, hepatitis B, and others. Due to this, the Red Cross and all blood collectors ask each potential donor about a history of vaccination to determine eligibility.

You can read more about vaccinations and donor eligibility under the Immunization, Vaccination tab of the donor eligibility page here: https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/eligibility-criteria-alphabetical.html.

Blood helps save lives

Blood is an essential, life-saving medicine. Every day, blood transfusions are used to treat patients with burns, battling cancer, during childbirth and surgery. A strong blood supply also saves lives during emergencies, allowing clinicians to provide critical care when minutes matter. Unlike other drugs, blood cannot be manufactured to meet demand.

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Those Who Receive COVID-19 Vaccine Are Able to Donate Blood - American Red Cross

We assessed the seroprevalence of anti-SARS-CoV-2 spike protein IgG antibodies among the staff members of a childrens hospital and found that pre-vaccination, seroprevalence was 8.8% in all staff members and 9.5% in HCWs. After receiving the first vaccine dose, seroprevalence increased to 9.3% in all staff members but remained unchanged in HCWs (9.5%). After the second vaccine dose, seroprevalence considerably increased to 50% in all staff members and 48.8% in HCWs.

Assaid et al. reported a seroprevalence of 65.9% by Euroimmun ELISA five months after the second dose of vector or inactivated virus vaccines in HCWs. The antibody response did not differ significantly between HCWs who received either vaccine type [8], which is consistent with our results, showing no relationship between vaccine type and seroprevalence by adjusted logistic regression analysis. The higher seroprevalence in Assaid et al.s study can be justified by demographic and anthropometric differences and history of prior COVID-19 infection as none of the HCWs in Assaid et al.s study had a history of COVID-19 infection [8]. A small group of our subjects were previously infected with COVID-19, but we found no association between such history and anti-SARS-CoV-2 IgG seroprevalence. Nonetheless, a single dose of the vaccine may be sufficient to induce an effective response in previously infected individuals, suggested by Gobbi et al. [9]

Interestingly, the seroprevalence of anti-SARS-CoV-2 after two doses of vector vaccines was 91.7% in HCWs of the study by Elangovan in India. They also observed a significant increase in antibody levels of HCWs who had a history of COVID-19 infection within six months prior to vaccination [10]. The much lower seroprevalence in our study might be due to almost one-third of subjects receiving inactivated virus vaccines, the interval between two doses of vaccines, as well as demographic differences and work settings. More importantly, the accuracy of measurements is always a matter of concern when evaluating laboratory parameters

Another explanation for the higher seroprevalence in Assaid et al.s study [8] can be the time of antibody assessment. We evaluated anti-SARS-CoV-2 antibodies at least two weeks after the second vaccine dose while their measurements were done five months after the second dose. The two-week interval was chosen in our study because according to previous investigations, individuals vaccinated at least 14 days before antibody measurements were presumed to be seronegative [11]. However, Costa et al. reported higher antibody values with shorter time lapse around two to eight weeks between vaccination and serology [12]

Another finding of the present study was the positive correlation of age with anti-SARS-CoV-2 IgG seroprevalence after the second dose of vaccination as every one-year increase in age increased the odds of positive anti-SARS-CoV-2 IgG by 6%. Yet, the oldest subject in our study was 60 years old. Contrary to our findings, by studying antibody responses in 212,102 individuals, Ward et al. showed a decrease in antibody response with age, but this reduction was most prominent at ages 75 years and above [13]. On the other hand, we found no association between sex and seroprevalence. Conversely, Costa et al. reported lower serological levels in males [12]. A lower antibody response to mRNA vaccines has been demonstrated in men compared to women in other studies [14, 15]. Of note, although vaccine type did not influence seroprevalence in our study, none of the subjects received mRNA vaccines

We found that a longer interval between the two doses of vaccines was associated with a lower seroprevalence of anti-SARS-CoV-2 IgG antibodies. On the contrary, it has been demonstrated that a three-month interval between the primary vaccine dose and the booster might result in a better immune response compared to a short dose interval, when vector vaccines were concerned [16]

In the current study, neither univariable nor multivariable binary logistic regression analysis showed an association between BMI and seroprevalence of anti-SARS-CoV-2 IgG antibodies after the second dose of vaccination. Obesity can negatively affect the immune system, and vaccine uptake may differ based on BMI. However, in line with our findings, the current COVID-19 trials have shown no difference between groups with normal and obese BMIs in terms of vaccine efficacy [17]. Similarly, no association between BMI and serological response has been reported in cohorts and cross-sectional studies [12, 18, 19]. Contrarily, Pellini et al. have reported that immunogenicity of SARS-CoV-2 vaccine may be impaired by obesity [20]. Consequently, it is necessary to conduct further studies to better understand whether the long-term effectiveness of COVID-19 vaccination depends on individuals BMI.

Understanding the immunological reaction that generates a protective immunization to SARS-CoV-2 is crucial [21]. In comparison to the membrane, envelope, and nucleocapsid proteins, antibody responses to the spike protein are considered to be the predominant focus of neutralizing activity during viral infection [22, 23]. However, it is important to note that only a proportion of anti-SARS-CoV-2 spike protein IgG antibodies have neutralizing capacity, and no neutralization assays were performed in the current study. Therefore, the seroprevalence of anti-SARS-CoV-2 spike protein IgG antibodies may not accurately reflect the neutralizing effects of vaccines. It has been demonstrated that declining levels of neutralizing antibodies are associated with an increased risk of symptomatic infection, although the relationship is less clear for severe infections [24]

The current investigation had some limitations. The association between seroprevalence and the number of vaccine doses could not be evaluated since only those staff members who received the second vaccine dose were tested again for anti-SARS-CoV-2 IgG. Moreover, although we took prior COVID-19 infection into account, it is not clear how long ago the infection occurred. This is important because IgG titer attenuates over time. Also, we did not assess neutralizing antibodies and cell-mediated immune responses

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Seroprevalence of anti-SARS-CoV-2 IgG antibodies pre- and post-COVID-19 vaccination in staff members of Bandar ... - BMC Infectious Diseases

The creation of what is called a pan vaccineone shot offering protection from multiple viruseshas been a goal for scientists and public health officials since the early days of the COVID-19 pandemic. The hope is that the availability of a safe, easy and convenient combo vaccine would increase the number of people getting the shot. More vaccinated people would thus improve public health, reducing the number of deaths from current COVID-19 variants and lessening the chances of another outbreak because more people would have built up immunity.

Recently, in an article in the journal Cell Reports, researchers at the Duke Human Vaccine Institute (DHVI) say they have created such a vaccine and have shown success with it in mouse studies. Human vaccine trials are next.

We are making important progress towards a broadly protective coronavirus vaccine, said Kevin Saunders, Ph.D., associate director of the institute. These are pathogens that cause or have the potential to cause significant human infections and loss of life, and a single vaccine that provides protection could slow down or even prevent another pandemic.

Researchers say the single nanoparticle vaccine included components of an earlier vaccine that protected mice and primates against multiple variants of SARS-CoV-2, the virus that causes COVID-19.

The DHVI team built the trivalent vaccine using a nanoparticle loaded with a key fragment called a receptor-binding domain that was taken from each strain of the coronaviruses. Think of the fragment as a docking site on the virus that enables it to infiltrate the bodys cells.

When the fragment is used this way, it provides enough information for the bodys immune cells to build an effective response against actual coronaviruses from those strains entering the body.

In earlier studies in mice and primates, researchers found the first versions of the nanoparticle vaccine were effective against multiple SARS-CoV-2 variants. The current study expands the components of the vaccine to include an additional SARS-related virus and a virus that causes Middle East Respiratory Syndrome, or MERS.

In lab studies and in studies involving mice, researchers found the vaccine generated immune molecules called antibodies against all three pathogenic human coronavirus types. Most important, the vaccinated mice did not get sick when exposed to either SARS-like or MERS-like viruses.

Human tests are now planned for a version that carries immunogens to different SARS-CoV-2 strains, including those that have dominated since the original outbreak in late 2019 that then spread throughout the world.

Tens of millions of people around the world were confirmed to have been infected by multiple strains of the COVID-19 virus. The virus killed millions more. It also devastated the worlds economy.

This study demonstrates proof-of-concept that a single vaccine that protects against both SARS and MERS viruses is an achievable goal, said Saunders. Given that one MERS and two SARS viruses have infected humans in the last two decades, the development of a universal coronavirus vaccine is a global health priority.

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Human Trials Start This Year on Dukes Combo Coronavirus Vaccine - PBS North Carolina

FRIDAY, Feb. 23, 2024 (HealthDay News) -- Maternal booster COVID-19 vaccination protects infants from infection in the first six months of life, according to a study published online Feb. 9 in Pediatrics.

Cristina V. Cardemil, M.D., M.P.H., from the National Institutes of Health in Rockville, Maryland, and colleagues quantified protection against infection from maternally derived vaccine-induced antibodies in the first six months of an infant's life. Full-length spike (Spike) immunoglobulin G (IgG), pseudovirus 614D, and live virus D614G and omicron BA.1 and BA.5 neutralizing antibody (nAb) titers were measured at delivery among infants born to mothers vaccinated during pregnancy with two or three doses of a messenger RNA COVID-19 vaccine.

The researchers found that Spike IgG, pseudovirus, and live nAb titers were significantly higher at delivery for 204 infants of boosted mothers than for 271 infants of nonboosted mothers; infants of boosted mothers were 56 percent less likely to acquire infection in the first six months. The infant's risk for acquiring infection was reduced by 47 percent for each 10-fold increase in Spike IgG titer at delivery, irrespective of boost. Risk reductions of 30, 46, 56, and 60 percent were seen in association with 10-fold increases in pseudovirus titers against Wuhan Spike, live virus nAb titers against D614G, and omicron BA.1 and BA.5 at delivery, respectively.

"We show that a monovalent booster dose during pregnancy leads to higher binding and nAb titers at delivery that are effective against omicron, for an age group that has the highest COVID-19-associated hospitalization rate in pediatrics since the emergence and ubiquitous spread of omicron variants," the authors write.

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

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Maternal Booster COVID Vaccination Protects Infants Through 6 Months - HealthDay

Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.

The rare events identified early in the pandemic included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTech SE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc.

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Largest Covid Vaccine Study Yet Finds Links to Health Conditions - Bloomberg

Cambodia's health ministry has reported another human infection from H5N1 avian influenza, part of an uptick in similar cases that began in 2023.

The patient is a 17-year-old girl from Kampot province, according to a ministry statement translated and posted by Avian Flu Diary, an infectious disease news blog. Kampot province is in southern Cambodia. The girl is hospitalized in the intensive care unit and is improving.

An investigation found that about 5 days before the girl's symptoms began, there were seven dead chickens at her home.

Cambodia has now reported 5 cases for 2024 and a total of 11 since February 2023, following nearly a decade with no human infections. Genetic sequencing on samples from several cases has revealed that the virus belongs to an older H5N1 clade (2.3.2.1c) that still circulates in poultry in some Asian countries, including Cambodia. It is different from the newer H5N1 clade (2.3.4.4b) that is currently affecting wild birds and poultry in multiple world regions, including the United States.

Elsewhere, Hong Kong's Centre for Health Protection (CHP) today reported an influenza A H9 case, which involves a 22-month-old girl who had recently visited the city of Zhongshan in mainland China's Guangdong province. Her symptoms began on February 15, and she was seen at a hospital the next day but was not admitted. Plans are under way for her to receive care in hospital isolation.

An investigation revealed that she had no direct contact with poultry during her incubation period while visiting the mainland, nor did she eat undercooked poultry or have contact with sick people. One of her home contacts had a sore throat on February 17 that subsided.

The CHP said novel H9 flu virus infections, including H9N2, are typically mild. Hong Kong has reported nine cases since 1999, and its most recent casefrom 2020was also imported.

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COVID vaccine mandates may have had unintended consequences, researchers say - University of Minnesota Twin Cities

In a recent study published in JAMA Oncology, researchers used data from all 50 United States (US) states and the District of Columbia to compare observed and projected cancer rate patterns from March to December 2020.

Study:Undiagnosed Cancer Cases in the US During the First 10 Months of the COVID-19 Pandemic. Image Credit:Image Point Fr/Shutterstock.com

The coronavirus disease 2019 (COVID-19) significantly influenced cancer identification in the US, with a lack of countrywide studies based on cancer registries.

Although the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection in 2019 caused enormous disruptions, cancer dangers persisted.

A drop in cancer incidences during 2020 may not imply a decrease in cancer occurrence but rather undiagnosed new tumors.

Although researchers expected the negative correlation of the COVID-19 pandemic responses with cancer detection, the data required to quantify this extent was inaccessible in the United States until recently.

In the present population-level cross-sectional study, researchers used the 2001-2020 United States Cancer Statistics database data to examine the delays and interruptions in cancer diagnosis during the initial COVID-19 wave. The team examined trends utilizing data from invasive cancer diagnostic cases documented by the United States Cancer Statistics between 1 January 2018 and 31 December 2020, age-adjusted for the United States Standard Population in 2000. They studied data from 6 to 28 July 2023.

The study's exposures included age, gender, race, urbanization, and the state's response to the pandemic during the cancer diagnosis period.

The researchers performed time-series forecasting to generate predicted cancer incidences between 1 March and 31 December 2020 based on prepandemic patterns (between January 2018 and February 2020).

They excluded Nevada and Indiana due to 2020 data unavailability and patients with an unclear month of cancer diagnosis. They investigated patients with invasive cancer diagnoses from 2018 to 2020 and calculated monthly all-site cancer incidence.

The team used the World Health Organization's 2008 International Classification of Diseases for Oncology, Third Revision (ICD-O-3) to identify new cancer sites and site groupings.

They identified screenable malignancies based on the United States Preventive Services Task Force recommendations: lung and bronchus, colon and rectum, breast (only in women), and cervix uteri. The researchers assessed incidence rates for the eligible population stratified by age, gender, urbanicity, race, state of residency, and state-level responses to the COVID-19 pandemic and the tumor stage at detection.

They categorized participant age by Medicare criteria (below 65 or 65 years), race using Race Recode variables, and urbanicity using the Rural-Urban Continuum Codes of 2013. The team grouped COVID-19 responses by state of residency based on the duration of stay-at-home rule enforcement in each state in spring 2020.

They converted the monthly age-stratified cancer incidences observed between January 2018 and December 2020 into time series by cancer group and site, fitting the time series to autoregressive integrated moving average (ARIMA) statistical models for analysis.

The study examined 1,297,874 tumor cases recorded in the United States between 1 March and 31 December 2020, yielding a cancer incidence rate of 327 cases per individual.

The observed all-site cancer incidence rates were 29% lower than projected during the peak of the SARS-CoV-2 pandemic response (between March and May 2020), 6.3% lower between June and December 2020, and 13% lower overall over the pandemic's initial ten months. The finding indicates 134,395 probably undetected malignancies throughout that period.

Prostate cancers were the most possibly missed type (22,950 cases), followed by breast cancers (16,870 cases) and lung cancers (16,333 cases). Screenable malignancies had a 14% lower overall rate than predicted.

Breast cancer rates improved from prior patterns after the initial three months of COVID-19, while levels of lung, colorectal, and cervical cancers remained low.

Between March and May 2020, states with highly stringent pandemic responses saw considerably more disruptions; however, these variations were non-significant by December 2020 for all locations except pancreatic, renal, and lung cancers.

Every cancer location studied exhibited statistically significant disturbances between March and May 2020, with melanoma diagnoses being 43% fewer than predicted.

Disruptions in late-stage lung cancer diagnoses were much higher than in breast and cervical malignancies but equal to those in late-stage colorectal cancer incidence. From March 1 to December 31, 2020, all non-screenable malignancies had statistically significant disturbances in the early and late stages. Between March 1 and May 31, 2020, all-site cancer incidence rates were considerably higher in states with more restricted COVID-19 responses, as well as among those aged 65 and over.

Overall, the study findings showed that the SARS-CoV-2 pandemic in the United States considerably influenced cancer incidence rates, with over 13,000 cases going undiscovered between March and December 2020.

This knowledge is critical for cancer prevention and control efforts, underscoring the importance of future catastrophe preparation in influencing cancer diagnosis.

The study discovered significant decreases in early- and late-stage colorectal cancer incidence, with female breast cancer demonstrating rate recovery during the most stringent pandemic response phase. Government programs should focus on reengaging patients and reducing missed appointments.

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How did COVID-19 impact cancer incidence trends in the US? - News-Medical.Net